[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimers-disease":64},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,81,0,25,[9,48,80,109,135,155,178,199,228,252,272,295,318,337,359,385,407,423,445,463,487,523,539,561,584],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100606576","phase-3-screening-study-to-determine-individuals-with-potential-trial-eligibility-for-alzheimers-disease-studies-100606576",false,"NCT07177352","Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies","Master Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies as Assessed by Biomarker Status and Cognition","TRAVELLER","Inclusion Criteria:\n\n* Ability and willingness to participate in an interventional clinical study, including meeting key eligibility criteria of linked interventional Roche AD studies (e.g., specific age ranges)\n* Ability and willingness to receive information about potential eligibility in an associated interventional Roche AD study\n\nExclusion Criteria:\n\n* Dependency in basic activities of daily living (bADLs) due to cognitive impairment\n* Visual or auditory impairment that would prevent them from performing the cognitive assessments (eyeglasses and hearing aids are permitted)\n* Any self-reported evidence or known diagnosis of a neurological or neurodegenerative condition that may lead to cognitive impairment other than AD\n* History of severe, clinically significant central nervous system trauma\n* Any serious medical condition that precludes a participant's safe participation and completion of a clinical study\n* For participants with a clinical diagnosis of MCI or mild AD: Previous AD diagnosis based on biomarker confirmation with an approved or validated rule in method (e.g., amyloid PET or cerebrospinal fluid, blood biomarker) is exclusionary","ALL","50 Years","90 Years",{"count":22,"type":23},80000,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.",[29],"Alzheimers Disease",[31,32,33,34],"Early Alzheimers Disease","Mild Cognitive Impairment","Mild Dementia","Preclinical AD","RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":39},"2025-07-02",{"date":43,"type":23},"2035-07-31",{"name":45,"class":46},"Hoffmann-La Roche","INDUSTRY",212,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100652901","phase-1-a-study-to-evaluate-the-drug-levels-absolute-bioavailability-safety-tolerability-and-immunogenicity-of-single-dose-of-bms-986446-in-healthy-adults-after-single-dose-administration-and-participants-with-early-alzheimers-disease-after-multiple-dose-administration-100652901","NCT07780383","A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration","A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.","Inclusion Criteria\n\n* Participants must have a BMI of 18.0 to 35.0 kg\u002Fm2.\n* For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.\n* For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.\n* For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).\n* For Part C: Participants must have evidence of positive plasma pTau217.\n\nExclusion Criteria\n\n* For Parts A and B: Participants must not have a general history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.\n* For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.\n* For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.\n* For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"18 Years","80 Years",{"count":59,"type":23},84,[61],"PHASE1","The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration",[64,65],"Alzheimer's Disease","Healthy Participants",[65,67,68,69,70],"Early Alzheimer's Disease","BMS-986446","Subcutaneous Administration","IV administration","NOT_YET_RECRUITING","2026-08-19",{"date":38,"type":39},{"date":38,"type":23},{"date":76,"type":23},"2027-06-17",{"name":78,"class":46},"Bristol-Myers Squibb",1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":24,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100591114","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt--karx-ec-for-cognitive-impairment-in-alzheimers-disease-100591114","NCT06976216","A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)","MINDSET 1","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.\n* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.\n* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.\n* Participants on acetyl choline esterase inhibitors (AChEIs) and\u002For memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.\n\nExclusion Criteria\n\n* Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \\\u003C50 mL\u002Fmin), and unstable hypertension or tachycardia.\n* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.\n* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.\n* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","60 Years","85 Years",{"count":91,"type":23},586,[26],"The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease",[64],[96,97,98,99,100,101],"Dementia","Cognitive Impairment","Kar-XT","KarX-EC","Mild Alzheimer's Disease","Moderate Alzheimer's Disease",{"date":36,"type":39},{"date":104,"type":39},"2025-07-14",{"date":106,"type":23},"2029-02-23",{"name":78,"class":46},119,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":88,"maxAge":89,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":79},"100652942","acupressure-as-long-term-intervention-to-slow-the-progression-of-earlymild-alzheimers-disease-100652942","NCT07779863","Acupressure as Long-term Intervention to Slow the Progression of Early\u002FMild Alzheimer's Disease","Caregiver-administered Acupressure as Long-term Intervention to Slow the Progression of Early\u002FMild Alzheimer's Disease With Blood Amyloid and Tau Biomarkers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* have at least one of the following abnormal plasma amyloid and tau levels: Aβ42\u002FAβ40 ratio ≤ 0.17, p-tau217 \\> 0.15 pg\u002Fml, or\u002Fand p-tau181 \\> 3.3 pg\u002Fml\n* have mild neurocognitive disorder with the Montreal Cognitive Assessment, Hong Kong version (HK-MoCA) in classifying mild neurocognitive disorder, in which mild neurocognitive disorder is defined as those whose HK-MoCA score falls between the 16th and 2nd percentile of his\u002Fher peers adjusted for age and education\n\nExclusion Criteria:\n\n* show moderate-to-severe dementia, as evidenced by a HK-MoCA score falling below the 2nd percentile of his\u002Fher peers adjusted for age and education\n* cannot proficiently communicate due to language function impairment\n* have severe skin lesions on acupressure areas\n* had a surgery on the head or neck\n* have a medical condition that is a contraindication for acupressure.",{"count":117,"type":23},188,[119],"NA","This is an assessor-blinded, randomized controlled trial. A total of 188 older adults aged 60-85 years with early\u002Fmild AD will be recruited from care and attention homes for the elderly and elderly activity centres. They will be randomly assigned to receive least acupressure control (LAC) (n = 94) and CAE (n = 94), administered by caregivers (i.e., trained research assistants), for 3 sessions a week for 12 months. The primary outcome is the change in the MoCA score from baseline. The secondary outcomes include functional independence, psychological well-being, sleep quality, and health-related quality of life. The outcomes will be assessed at baseline and once bimonthly thereafter, totalling 7 sessions. A linear mixed-effect model will be applied to compare the primary and secondary outcomes. Three blood samples will be collected at baseline, 6 months, and 12 months, respectively, and the baseline blood sample will be immediately measured for the measurement of plasma Aβ42, Aβ40, p-tau181, and p-tau217, GFAP, and NfL. Repeated two-way variance (ANOVA) will be used to detect significant differences in blood biomarkers between the two groups. Linear regression will be conducted to examine inter-correlations between clinical outcomes and biomarker levels. Health and social care resource use will additionally be recorded at baseline, 6 months, and 12 months for the economic evaluation to examine the cost-effectiveness of the CAE intervention compared with LAC.",[64],[123,124,96,125],"Alzheimer's disease","Acupressure","Amyloid and tau biomarkers","2026-08-18",{"date":38,"type":39},{"date":129,"type":23},"2027-01-01",{"date":131,"type":23},"2030-08-31",{"name":133,"class":134},"The University of Hong Kong","OTHER",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":79},"100651127","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-dnl921-in-healthy-participants-and-participants-with-alzheimers-disease-100651127","NCT07758595","A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease","A Phase 1\u002F1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Dose and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease","Key Inclusion Criteria (Healthy Participants):\n\n* Are male or female of non-childbearing potential and are aged 18 through 60 years at the time of screening\n* Have a BMI of 18 through 32 kg\u002Fm2 and a body weight of at least 50 kg\n* For female participants: Are of non-childbearing potential\n* For male participants: Are surgically sterile by bilateral orchidectomy, or are abstinent, or agree to use two acceptable forms of contraception\n\nKey Exclusion Criteria (Healthy Participants):\n\n* Have any history of clinically significant neurological, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematological, immunological, or allergic disease, or other major disorders\n* Have a positive serum pregnancy test or are currently lactating or breastfeeding\n* Have been hospitalized during the 4 weeks prior to screening\n\nKey Inclusion Criteria (Participants with AD):\n\n* Are male or female of non-childbearing potential and aged 50 to 75 years at the time of screening\n* Have a BMI between 18 and 32 kg\u002Fm2 and a body weight of at least 45 kg\n* Have a diagnosis of probable mild to moderate AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD)\n* Have supportive evidence of AD pathology by the following:\n\n  * Plasma ptau217\u002FAbeta42 positive\n  * Positive amyloid PET scan\n* For female participants: Are of non-childbearing potential\n* For male participants: Are surgically sterile by bilateral orchidectomy, or are abstinent, or agree to use two acceptable forms of contraception\n\nKey Exclusion Criteria (Participants with AD):\n\n* Have other clinically significant neurological or cognitive disorders affecting the CNS, as determined by the investigator, other than AD\n* Have specific psychiatric conditions\n* Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment\n* Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies treated with curative intent (such as prostate cancer) at low risk of recurrence\n* Have a positive serum pregnancy test or are currently lactating or breastfeeding\n* Have been hospitalized during the 4 weeks prior to screening\n* Have had previous anti-amyloid or anti-tau immunotherapy (including active immunization) or have participated in experimental gene therapy or cell therapy at any time","75 Years",{"count":144,"type":23},178,[61],"This is a Phase 1\u002F1b, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL921 in healthy participants and participants with Alzheimer's disease (AD). The principal aim of this study is to obtain safety and tolerability data. This information, together with PK and PD data, will inform dose selection and design of future studies.",[64,65],{"date":36,"type":39},{"date":150,"type":39},"2026-08-07",{"date":152,"type":23},"2030-04",{"name":154,"class":46},"Denali Therapeutics Inc.",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":24,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":79},"100652743","central-auditory-processing-modulation-underlying-anxiety-reduction-using-clinically-designed-improvisatory-music-100652743","NCT07775625","Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music","Inclusion Criteria\n\n* Clinical diagnosis of Alzheimer's Disease\n* Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF)\n* Mini-mental State Exam (MMSE) \\>=15\n* Rating for Anxiety in Dementia (RAID) score \\> 8\n\nExclusion Criteria\n\n* Significant hearing impairments\n* Major comorbidities Beck Depression Inventory (BDI) scores above \\> 10'","55 Years",{"count":163,"type":23},30,[119],"This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDIM has previously been shown to reduce stress and improve physiological markers such as heart rate, blood pressure, and EEG alpha\u002Fbeta ratios (CDIM significantly decreased physical stress symptoms and patients also reported positive emotional outcomes and EEG readings showed increased alpha\u002Fbeta brainwave ratios ).\n\nThe study will enroll 30 dyads (individuals with AD-A and their caregivers). Dyads will be randomly assigned to either CDIM or a control intervention (CI) consisting of calming short stories read aloud. Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats.\n\nThe primary goal is to determine whether CDIM is feasible and effective in reducing anxiety in individuals with AD-A, measured by the Rating Anxiety in Dementia (RAID) scale, and in reducing caregiver burden, measured by the Zarit Burden Interview (ZBI). The study also evaluates changes in heart rate and blood pressure as indicators of autonomic regulation.\n\nA second goal is to explore whether CDIM improves central auditory processing, assessed using the frequency-following response (FFR). The proposal notes that central auditory processing declines with age and dementia and may contribute to anxiety. FFR will be measured before and after the intervention to determine whether CDIM enhances neural timing and response magnitude.\n\nOverall, this pilot study aims to determine whether CDIM is a feasible, safe, and potentially effective non-pharmacological intervention for reducing anxiety in individuals with AD-A and decreasing caregiver burden, while also investigating its underlying neurophysiological mechanisms.",[64],[168,169,123],"Music-based intervention","Anxiety","2026-08-16",{"date":36,"type":39},{"date":173,"type":39},"2026-02-02",{"date":175,"type":23},"2026-12-15",{"name":177,"class":134},"Northwestern University",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":55,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":24,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":79},"100650796","phase-3-evaluate-the-concordance-between-pet-imaging-of-18f-apn-1607-injection-and-postmortem-brain-tissue-tau-pathology-in-individuals-with-hv-and-mci-or-ad-100650796","NCT07752784","Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD.","A Clinicopathological Study to Evaluate the Concordance Between [18F]-APN-1607 Injection PET Imaging and Post-mortem Brain Tau Protein Pathological Changes in Cognitively Normal (HV) Subjects and Patients With AD-derived Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Dementia.","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign a written informed consent form (ICF).\n2. Age≥50 years, male or female.\n3. Charlson Comorbidity Index (CCI)≥5.\n4. Able to tolerate imaging procedures.\n5. For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia.\n6. For HV subjects: no known personal or family history of AD-derived dementia.\n\nExclusion Criteria:\n\n1. Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area\\>4 cm) or intracranial space-occupying lesion.\n2. Currently having clinically significant infectious diseases: HIV, hepatitis, etc.\n3. Currently participating in any investigational clinical trial.\n4. Previous participation in clinical studies of amyloid or tau-targeting agents.\n5. Suspected hepatic encephalopathy.\n6. Allergy to the investigational drug or any of its components.\n7. Currently pregnant or breastfeeding.\n8. Currently having a disease or condition that prolongs the QT interval.",{"count":186,"type":23},12,[26],"1. To evaluate the diagnostic performance of \\[18F\\]-APN-1607 injection PET imaging in detecting uptake patterns consistent with AD neuropathological changes as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.\n2. To assess the association between \\[18F\\]-APN-1607 injection and Alzheimer's disease (AD)-related tau neurofibrillary pathology (as determined by post-mortem brain tissue histopathology), and detect the uptake pattern corresponding to neurofibrillary tangle (NFT) scores.\n3. To evaluate the safety of \\[18F\\]-APN-1607 injection.",[64],"2026-08-14",{"date":192,"type":39},"2026-08-17",{"date":194,"type":23},"2026-08-15",{"date":196,"type":23},"2027-08-15",{"name":198,"class":46},"JYAMS PET Research & Development Limited",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":24,"phases":209,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":79},"100392965","phase-1-pet-imaging-of-cyclooxygenases-in-neurodegenerative-brain-disease-100392965","NCT04396873","PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Agree to adhere to the lifestyle considerations.\n\nHealthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception\n3. Able provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL\n2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.\n4. Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and\u002For caregiver during the screening visit.\n9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.\n11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n12. Pregnancy\n13. HIV infection\n14. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.","99 Years",{"count":208,"type":23},184,[61],"Background:\n\nAbout 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.\n\nObjective:\n\nTo learn whether COX-1 and\u002For COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.\n\nEligibility:\n\nAdults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.\n\nParticipants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.\n\nParticipants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.\n\nParticipants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.",[212,96,64,213,32],"Parkinson's Disease","ALS",[215,216,217,96,218,213,219],"PET Imaging","PD","Inflammation","Cyclooxygenase-2","MCI",{"date":192,"type":39},{"date":222,"type":39},"2021-08-17",{"date":224,"type":23},"2030-10-03",{"name":226,"class":227},"National Institute of Mental Health (NIMH)","NIH",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100641813","phase-1-a-study-to-assess-the-safety-and-effects-of-abbv-1758-following-subcutaneous-or-intravenous-injections-in-participants-with-alzheimers-disease-100641813","NCT07599670","A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants meeting all the following criteria for Alzheimer's disease (AD):\n\n  * In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.\n  * Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).\n* Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.\n\nExclusion Criteria:\n\n* Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.\n* Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and\u002For any history of abnormal laboratory results that are indicative of significant disease(s).\n* Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.\n* Participants with other significant pathological findings on brain MRI at screening, including but not limited to:\n\n  * Evidence of vasogenic edema\n  * 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)\n  * Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)\n  * Any superficial siderosis\n  * Severe white matter disease",{"count":236,"type":23},210,[61,238],"PHASE2","Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.\n\nABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.\n\nParticipants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.",[64],[64,242],"ABBV-1758","2026-08-13",{"date":190,"type":39},{"date":246,"type":39},"2026-05-15",{"date":248,"type":23},"2030-10",{"name":250,"class":46},"AbbVie",11,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":259,"targetDuration":4,"studyType":24,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100651996","phase-1-a-study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-e2511-in-participants-with-early-alzheimers-disease-ad-100651996","NCT07768592","A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)","A Proof-of-Mechanism, Open-Label, Parallel Group Study With an Open-Label Extension Phase to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease","Inclusion Criteria:\n\n1. For participants diagnosed with mild cognitive impairment (MCI) due to AD-intermediate likelihood:\n\n   1. Meet the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood.\n   2. Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDR Memory Box score of greater than or equal to (\\>=) 0.5 at Screening and Baseline.\n2. For participants diagnosed with mild AD dementia:\n\n   1. Meet the NIA-AA core clinical criteria for probable AD dementia.\n   2. Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of \\>=0.5 at Screening and Baseline.\n3. Mini Mental State Examination (MMSE) score \\>=22 and less than or equal to (\\\u003C=) 30 at Screening.\n4. Evidence of brain amyloid pathology as indicated by one of the following:\n\n   1. Plasma phosphorylated tau217 (p-tau217) assay performed at Screening.\n   2. Historical plasma p-tau217 assay performed before screening.\n   3. Historical cerebrospinal fluid (CSF) or amyloid PET assessment performed before Screening.\n5. Nonsmoking and nonvaping, male or female, aged \\>=50 years and \\\u003C=85 years old, at the time of informed consent.\n6. Body Mass Index (BMI) greater than 17 and less than 35 at Screening.\n7. Have an identified trial partner (defined as a person able to support the participant for the duration of the trial and who spends at least 8 hours per week with the participant). The trial partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the participant throughout the course of the trial. This person must, in the opinion of the investigator, spend sufficient time with the participant on a regular basis such that the trial partner can reliably fulfill the trial requirements. A permanent trial partner need not be living in the same residence with the participant. For such a trial partner not residing with the participant, the investigator has to be satisfied that the participant can contact the trial partner readily during the times when the trial partner is not with the participant. If in doubt about whether a participant's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Trial partners need to participate in person for visits where clinical assessments, such as CDR (global and CDR-SB), take place.\n8. Able to undergo CSF lumbar puncture and not receiving any anticoagulant therapy or currently suffering from a medical condition that may require initiation of any anticoagulant therapy at Screening.\n9. Provide written informed consent. If a participant lacks the capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required in accordance with local laws, regulations, and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).\n10. Willing and able to comply with all aspects of the protocol including multiple CSF collections.\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[β-hCG\\] or human chorionic gonadotropin \\[hCG\\] test with a minimum sensitivity of 25 International Units per Liter \\[IU\u002FL\\] or equivalent units of β-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of trial drug.\n2. Females of childbearing potential who:\n\n   * Within 28 days before trial entry, did not use a highly effective method of contraception, which includes any of the following:\n\n     * total abstinence (if it is their preferred and usual lifestyle)\n     * an intrauterine device or intrauterine hormone-releasing system (IUS)\n     * a contraceptive implant\n     * an oral contraceptive (participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the trial and for 28 days after trial drug discontinuation)\n     * have a vasectomized partner with confirmed azoospermia.\n   * Do not agree to use a highly effective method of contraception (as described above) throughout the entire trial period and for 28 days after trial drug discontinuation.\n\n   NOTE: It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e., double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical\u002Fvault cap with spermicide. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (i.e., the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the trial period and for 5 times the half-life of the trial drug plus 90 days after trial drug discontinuation). No sperm donation is allowed during the trial period and for 5 times the half-life of the trial drug plus 90 days after trial drug discontinuation.\n4. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's MCI or AD.\n5. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.\n6. Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders).\n7. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (i.e., answering \"Yes\" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS).\n8. Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS).\n9. Contraindications to magnetic resonance imaging (MRI) scanning, including cardiac pacemaker\u002Fdefibrillator, and ferromagnetic metal implants (eg, in skull and cardiac devices other than those approved as safe for use in MRI scanners).\n10. Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD.\n11. Other significant pathological findings on brain MRI at Screening, including but not limited to: evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 centimeter \\[cm\\] at their greatest diameter need not be exclusionary). Other minor or clinically insignificant MRI abnormalities, as agreed by the medical monitor and after discussion with the investigator, may not be exclusionary.\n12. Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, localized prostate cancer in male participants, or localized breast cancer in female participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.\n13. A clinically significant ECG abnormality, including a marked prolonged corrected QT interval (Fridericia's Correction Formula) (eg, a repeated demonstration of a QTcF interval greater than \\[\\>\\] 450 milliseconds \\[ms\\]).\n14. Participants with a bleeding disorder that is not under adequate control (including a platelet count \\\u003C50,000 or international normalized ratio \\[INR\\] \\>1.5). Participants who are on anticoagulant therapy are not permitted to be enrolled.\n15. Have thyroid-stimulating hormone above the normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all participants whether or not they are taking thyroid supplements. If the thyroid-stimulating hormone returns to normal range with thyroid replacement therapy, then participants may be allowed to enroll without rescreening if they meet all other inclusion criteria and did not meet any exclusion criteria.\n16. Abnormally low serum vitamin B12 levels for the testing laboratory (if a participant is taking vitamin B12 injections, level should be at or above the lower limit of normal for the testing laboratory). Levels of vitamin B12 may be confirmed with reflex testing to include methylmalonic acid analysis, if available in the region. If vitamin B12 levels return to normal range with supplement treatment, then participants may be allowed to enroll without rescreening if they meet all other inclusion criteria and did not meet any exclusion criteria.\n17. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, and renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the trial assessments. Any other medical conditions (eg, cardiac, respiratory, gastrointestinal, and renal disease) that are not stably and adequately controlled or that in the opinion of the investigator(s) could affect the participant's safety or interfere with the trial assessments.\n18. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the trial.\n19. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the trial. Planned surgery that requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with trial procedures and participant's safety.\n20. Known to be human immunodeficiency virus positive.\n21. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Participants who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if, in the clinical opinion of the investigator, this is due to the participant taking prior\u002Fconcomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse.\n22. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately.\n23. Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening.\n24. Currently enrolled in another clinical trial or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent.\n25. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.\n26. Participants who contravene the restrictions on medications, food, beverages, physical activities, and others as defined in the protocol at Screening or Baseline.\n27. Participants with contraindications to lumbar puncture.\n28. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.\n29. Taking a cholinesterase inhibitor unless willing to discontinue cholinesterase inhibitor treatment for 21 days before Screening and until the last visit during the Core Trial.\n30. Participation in a clinical trial for AD involving any antisense oligonucleotide or silencing ribonucleic acid (RNA) therapies targeting amyloid or tau unless it can be documented that the participant only received placebo.\n31. Participation in a clinical trial for AD involving pharmaceutical intervention other than antisense oligonucleotide or silencing RNA therapies (eg, small molecules, monoclonal antibodies) within 6 months of Screening unless it can be documented that the participant only received placebo.\n32. Participants who have taken approved anti-amyloid monoclonal antibodies (eg, LEQEMBI, KISUNLA) within 6 months of Screening.\n33. Any history of surgery that may affect pharmacokinetic (PK) profiles of trial drug (eg, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.\n34. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.",{"count":260,"type":23},32,[61],"The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts. In Part A, participants will be randomly assigned to receive either E2511 or donepezil. In Part B, participants will receive E2511 only. Once Part A and Part B participants complete the Core Trial (which includes Pretreatment and Treatment phases) they will have the option to enter the Extension Phase where they will receive E2511 for 18 months.",[29],"2026-08-12",{"date":192,"type":39},{"date":267,"type":23},"2026-10-15",{"date":269,"type":23},"2030-05-06",{"name":271,"class":46},"Eisai Inc.",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":279,"targetDuration":281,"studyType":282,"phases":4,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":251},"100651636","a-post-authorization-registry-study-of-participants-treated-with-leqembi-100651636","NCT07762092","A Post Authorization Registry Study of Participants Treated With LEQEMBI","Post Authorization Registry Study of Patients Treated With LEQEMBI","Inclusion Criteria:\n\n* Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.\n\nExclusion Criteria:\n\n* None",{"count":280,"type":23},400,"3 Years","OBSERVATIONAL","To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \\[CAA\\]).\n\nThe secondary purpose of this study is,\n\nTo describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.\n\nTo describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).\n\nTo describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.",[29],[64,67,286,287],"LEQEMBI","ARIA",{"date":243,"type":39},{"date":290,"type":23},"2026-07-31",{"date":292,"type":23},"2036-04-01",{"name":294,"class":46},"Eisai Limited",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":302,"maxAge":57,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100609449","phase-1-a-study-to-evaluate-aln-5288-in-patients-with-alzheimers-disease-100609449","NCT07214727","A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease","A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease","Inclusion Criteria:\n\n* Is able and willing to meet all study requirements in the opinion of the Investigator\n* Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening\n* Has mild cognitive impairment (MCI) or dementia due to AD\n\nExclusion Criteria:\n\n* Has non-AD dementia\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× upper limit of normal (ULN)\n* Has total bilirubin \\>1.5×ULN\n* Has known human immunodeficiency virus infection\n* Has history of hepatitis C virus or current hepatitis B virus infection\n* Has systolic blood pressure \\>160 mmHg and\u002For a diastolic blood pressure \\>100 mmHg after 10 minutes of rest at screening\n* Has an estimated glomerular filtration (eGFR) of \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2 at screening\n* Has clinically significant ECG abnormalities at screening\n* Has uncontrolled psychiatric disease, including patients deemed by the Investigator to be at significant risk of suicide, major depressive episode, psychosis, confusional state, or violent behavior\n* Has history of bleeding diathesis or coagulopathy due to chronic conditions\n* Has a medical history of brain or spinal disease that would interfere with the IT injection and LP procedures\n* Has history of uncontrolled seizures within the last 6 months prior to Screening","40 Years",{"count":304,"type":23},50,[61],"The purpose of this study is to:\n\n* Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD)\n* Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after dose administration",[64],[309,96],"AD",{"date":190,"type":39},{"date":312,"type":39},"2025-10-15",{"date":314,"type":23},"2030-03-06",{"name":316,"class":46},"Alnylam Pharmaceuticals",13,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":88,"maxAge":89,"enrollmentInfo":326,"targetDuration":4,"studyType":24,"phases":327,"briefSummary":93,"conditions":328,"keywords":329,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":335,"locationsCount":336},"100591113","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt--karx-ec-for-cognitive-impairment-in-alzheimers-disease-mindset-2-100591113","NCT06976203","A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)","MINDSET 2","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.\n* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.\n* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.\n* Participants on acetyl choline esterase inhibitors (AChEIs) and\u002For memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.\n\nExclusion Criteria:\n\nParticipants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \\\u003C50 mL\u002Fmin), and unstable hypertension or tachycardia.\n\n* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.\n* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.\n* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":91,"type":23},[26],[64],[96,97,98,99,100,101],"2026-08-11",{"date":264,"type":39},{"date":333,"type":39},"2025-07-21",{"date":106,"type":23},{"name":78,"class":46},126,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":89,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":79},"100646618","a-study-to-investigate-the-safety-and-effectiveness-of-sar448851-in-participants-with-early-alzheimers-disease-100646618","NCT07688213","A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease","TREMHANCE","Inclusion Criteria:\n\n* Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.\n* Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \\[NIA-AA\\] Stage 3) or mild AD dementia (NIA-AA Stage 4).\n* Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.\n* Have a study partner who must provide separate written informed consent at screening. Study partner should be \\>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.\n* The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.\n\nExclusion Criteria:\n\n* The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).\n* The participant has evidence of more than 4 microhemorrhages (\\\u003C10 mm in diameter) or superficial siderosis.\n* The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4\u002F4).\n* The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.\n* The participant is currently receiving anticoagulant therapies.\n* The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":346,"type":23},160,[238],"This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.\n\nThis Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.\n\nThe study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.\n\nUp to 160 participants will be included in this study.",[350,64],"Dementia, Alzheimer's Type",{"date":352,"type":39},"2026-08-10",{"date":354,"type":39},"2026-07-28",{"date":356,"type":23},"2029-07-31",{"name":358,"class":46},"Sanofi",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":55,"sex":18,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":24,"phases":370,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":79},"100648522","phase-2-neuroplasticity-enhancement-from-cognitive-training-reinforced-by-psilocybin-100648522","NCT07721467","Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin","Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Capacity to provide informed consent.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, age \\>= 65 years old.\n* Cognitive Status:\n* Early-stage AD population: Meets the 2024 Alzheimer s Association Workgroup revised criteria for diagnosis and staging of AD (symptomatic cognitive impairment consistent with amnestic MCI or mild AD dementia) with a CDR score of 0.5-1(including 0.5 for the memory box) and a Montreal Cognitive Assessment (MoCA) score of 20-25.5\n* Cognitively normal population: No cognitive impairment based on clinical history and examination, with a CDR score of 0 and MoCA score \\>= 26.\n* For participants with early-stage AD, evidence of underlying AD pathology by the currently only FDA-approved blood-based test, Lumipulse G p217-Tau\u002FAbeta42 ratio \\>= 0.00738.123 Alternatively, participants who had previously underwent amyloid PET or CSF testing for diagnosis of AD (to qualify for treatment with anti-amyloid monoclonal antibodies or for any other reason) may provide report of the amyloid PET scan or result of CSF analysis compatible with underlying AD pathophysiology; Lumipulse G p217- Tau\u002FAbeta42 will still be measured to maintain consistency in study assessments, but values \\\u003C 0.00738 will not disqualify them.\n* Absence of serious neuropsychiatric symptoms, defined as a score of 0 on Delusions and Hallucinations items and a score \\\u003C= 2 on Anxiety, Aggression, Irritability, and Disinhibition items of the Neuropsychiatric Inventory Questionnaire (NPI-Q).\n* Acetylcholinesterase inhibitors and\u002For memantine are permitted (alone or in combination) provided the dose(s) have been stable for (Bullet) 6 weeks prior to screening and are expected to remain stable through the psilocybin dosing period and primary outcome assessments, unless a change is medically necessary as determined by the prescribing clinician.\n* Concurrent pharmacotherapy with a single selective serotonin reuptake inhibitor (SSRI) other than fluoxetine, serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic anti-depressant (TCA) or monoamine oxidase inhibitor (MAOI) is allowed only if the participant is willing and able to taper off this medication after Visit 1 (Screening) and have stayed off it for a washout period of at least 7 +\u002F- 2 days prior to Visit 2 (Baseline) and at least 14 +\u002F- 2 days prior to Visit 3 (for the Psilocybin + Cognitive Training group) or Visit 4 (for the Cognitive Training alone group). Bupropion (\\\u003C= 300 mg\u002Fday) is permitted without taper or washout if the dose has been stable for \\>= 6 weeks before screening.\n* Absence of active suicidal ideation with plan\u002Fintent and no suicidal behavior within the past 6 months, as defined by Columbia-Suicide Severity Rating Scale (C-SSRS) of 0 or 1. Participants with passive ideation (severity 1) may be included only if risk is judged low, a safety plan is documented, and there is no suicidal behavior in the prior 6 months.\n* For the early-stage AD population, participation of a study partner who is willing and able to serve as a medical history informant, accompany participants during visits, and provide psychological support following psilocybin sessions. For the cognitively normal population, participation of a study partner will be encouraged, but will not be mandated as eligibility criterion.\n* Ability to take oral medication.\n* Pregnancy prevention:\n* Participants of childbearing potential must have a negative urine pregnancy test at screening and prior to psilocybin on Visits 3 and 7, and agree to use highly effective birth control beginning at least 14 days before any psilocybin dosing day and continuing through 30 days after the last psilocybin dose.\n* Male participants with partners of childbearing potential must agree to use condoms and to ensure their partner uses a highly effective contraceptive method during the same window. Sperm donation is not permitted during the study and for 30 days after the last psilocybin dose.\n\nNote: The Lumipulse G p217-Tau\u002FAbeta42 plasma ratio (Fujirebio Diagnostics, Inc) has received FDA clearance as the first blood-based biomarker to aid in the diagnosis of AD in symptomatic patients \\>= 50 years old. It is being used in both clinical practice and research trials as a biomarker of AD pathology. In this study, the Lumipulse G p217-Tau\u002FAbeta42 ratio will serve as the eligibility biomarker for the early-stage AD group, with a cutoff value of \\>= 0.00738.123\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Medical history\n\n--Neurological disorders (besides AD): Clinically significant brain disorders, either previously diagnosed or revealed through the screening exams or baseline neuroimaging, including:\n\n* Stroke (except single asymptomatic old lacune)\n* Transient Ischemic Attack (TIA) within the past year, unless full work-up reveals no ongoing risk\n* Extensive microvascular pathology or microbleeds\n* Multiple sclerosis or related demyelinating disorders\n* Parkinson s disease or related movement disorders (e.g., Multiple Systems Atrophy, Progressive Supranuclear Palsy)\n* Brain tumors\n* History of meningitis or encephalitis\n* History of moderate\u002Fsevere traumatic brain injury (Glasgow Coma Scale \\\u003C= 12)\n* Other dementias (e.g., vascular dementia, mixed neurodegenerative-vascular dementia, Lewy body disease, frontotemporal dementia, primary progressive aphasia, Huntington s disease, corticobasal degeneration)\n* Epilepsy\n\nStable, mild neurological conditions (e.g., migraine, essential tremor, peripheral neuropathy) may be allowed at the discretion of the medically responsible investigator.\n\n--Psychiatric disorders:\n\n* Current or past moderate-to-severe mood disorders (e.g., treatment-resistant depression, bipolar disorder)\n* History of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder) unless psychosis was remote, short-lived, and directly attributable to medication misuse or overdose\n* Suicidal ideation or behavior: Active suicidal ideation (C-SSRS severity 2-5) within the past 1 month or any suicidal behavior within the past 6 months; or current elevated acute risk in the opinion of the medically responsible investigator based on C-SSRS plus clinical interview.\n* Severe PTSD, defined as a Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) score \\>= 4 in men or \\>= 3 in women\n* Anxiety or personality disorders, if moderate to severe, as determined by the medically responsible investigator.\n\nMild depression and\u002For anxiety may be permitted if successfully treated with psychotherapy and\u002For single anti-depressant agent (i.e., SSRI, SNRI, TCA, MAOI or bupropion). However, given the potential for serotonergic antidepressants to blunt psilocybin s effect or increase risk124,125, participants taking a single SSRI, SNRI, TCA, or MAOI other than fluoxetine may still be eligible only if they are willing and able to taper off this medication after Visit 1 (Screening) and complete a washout period of at least 7 +\u002F- 2 days prior to Visit 2 (Baseline) and at least 14 +\u002F- 2 days prior to Visit 3 (for the Psilocybin + Cognitive Training group) or Visit 4 (for the Cognitive Training alone group). Tapering of eligible non-fluoxetine antidepressants will be treated as an eligibility criterion and will occur only when all of the following are true: (i) the participant wishes to proceed after discussion of risks\u002Fbenefits, (ii) the prescribing clinician agrees tapering is reasonable and safe, and (iii) the medically responsible investigator agrees there is no elevated risk based on psychiatric history, current symptoms, and overall clinical picture. Discontinuation will not be abrupt. A written taper plan (dose-reduction schedule and monitoring plan) will be documented in coordination with the prescribing clinician, including a clear point of contact if symptoms worsen. During taper\u002Fwashout, the study team will conduct scheduled weekly safety check-ins by phone focused on withdrawal\u002Fdiscontinuation symptoms, mood\u002Fanxiety worsening, sleep disruption, and suicidal ideation\u002Fbehavior. If clinically significant symptom worsening or other safety concerns occur, the taper will be slowed, paused, or stopped, and clinical management will be redirected to the treating clinician; the participant may be excluded from further participation for safety reasons.\n\n* Cardiovascular conditions:\n\n  * Any history of coronary artery disease\n  * Clinically significant electrocardiographic (EKG) abnormalities (e.g., atrial fibrillation\u002Fflutter, QTc \\> 450 ms, evidence of myocardial infarct history, highgrade conduction disease, or other rhythm\u002Fconduction abnormalities) as determined by the PI\u002Fmedically responsible investigator. For EKG abnormalities other than QTc \\> 450 ms, clinical significance may be corroborated by transthoracic echocardiogram (TTE).\n  * Uncontrolled hypertension (systolic blood pressure (SBP) \\> 150 mmHg or diastolic blood pressure (DBP) \\> 95 mmHg) confirmed after appropriate rest and repeated measurements: blood pressure will be measured in the seated position after \\>= 5 minutes of quiet rest, using an automated device and appropriate cuff size; three measurements will be obtained 1-2 minutes apart, and the average of them will be used for eligibility determination (a repeat set may be obtained after additional rest if initial readings are elevated).\n  * Resting heart rate (HR) \\\u003C= 55 bpm or \\> 100 bpm or clinically significant arrythmia: HR will be assessed concurrently with the blood pressure protocol above (seated after \\>= 5 minutes of rest), using the same repeated-measurement approach and corroborated by clinical assessment\u002FEKG when indicated.\n  * Clinically significant cardiomyopathy (e.g., hypertrophic, dilated, restrictive) or heart failure\n  * Moderate to severe valvular heart disease (valvulopathy) or pulmonary hypertension\n* Metabolic disorders:\n\n  * Insulin-dependent diabetes mellitus\n  * Renal impairment (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m\\^2)\n  * Liver function tests \\> 2x upper limit of normal\n* Infectious \\& Hematologic Conditions:\n\n  * Positive HIV, HBV, or HCV status\n  * Anemia (HGB \\\u003C 12 g\u002FdL in men, \\\u003C 11 g\u002Fdl in women)\n* Poor venous access\n\n  -Medications Exclusions\n* Absolute\n\n  * Typical \\& atypical antipsychotics\n  * Multiple antidepressants medications (i.e., combinations of SSRIs, SNRIs, MAOIs, TCAs and bupropion). Participants taking a single SSRI, SNRI, MAOI, or TCA may still be eligible, if they are willing and able to taper off this medication after Visit 1 (Screening) and have stayed off it for a washout period of at least 7 +\u002F- 2 days prior to Visit 2 (Baseline) and at least 14 +\u002F- 2 days prior to Visit 3 (for the psilocybin + cognitive training group). Participants currently taking fluoxetine will be excluded at screening because of the long half-life of fluoxetine and its active metabolite norfluoxetine.126 The study team will not direct fluoxetine tapering for the purpose of study participation. Participants taking fluoxetine will be advised to discuss with their own physician(s) whether they still need to be on fluoxetine and whether they could safely taper it and stay off it for some period of time. If they are willing to do that and their physician(s) decide to stop fluoxetine, they may come back and be re-screened for this study at a later time, after at least 4 weeks have passed since the last fluoxetine dose (they would also need to otherwise meet eligibility criteria). Bupropion (\\\u003C= 300 mg\u002Fday) is permitted without taper or washout if the dose has been stable for \\>= 6 weeks before screening.\n* Relative\n\n  * Benzodiazepines and non-benzodiazepine sedative-hypnotics (e.g., zolpidem, eszopiclone):\n\n    * Regular use: participants must be willing and able to taper off and remain off for at least 14 +\u002F- 2 days prior to Visit 3 (for the psilocybin + cognitive training group) or Visit 4 (for the cognitive training alone group), due to potential confounding effects on EEG recordings and sleep architecture and potential attenuation of the acute psilocybin experience. Because benzodiazepine withdrawal can cause clinically significant symptoms (and, rarely, seizures), tapering must be gradual. Discontinuation schedule will be directed by the medically responsible investigator in coordination with the prescribing clinician per participant wishes; participants with evidence of physiologic dependence or for whom safe tapering is not feasible within the study timeline will not be eligible for further study participation.\n    * Intermittent PRN use: participants may be eligible if they can hold these medications for at least 72 hours prior to each psilocybin dosing session (for the psilocybin + cognitive training group) and avoid use during the overnight EEG recording window.\n  * Sleep-inducing medications (e.g., trazodone, sedative-hypnotics) should not be taken for at least 14 +\u002F- 2 days before Visit 3 (for the psilocybin + cognitive training group) or Visit 4 (for the cognitive training alone group) (due to potential confounding effects on EEG recordings and sleep architecture)\n  * Melatonin (and similar over-the-counter sleep aids) should not be taken for at least 72 hours prior to Visit 3 (for the psilocybin + cognitive training group) or Visit 4 (for the cognitive training alone group), due to potential confounding effects on EEG recordings\n  * Mood stabilizers (e.g., lithium), long-acting opioids (unless they are willing and able to taper off after Visit 1 (Screening) and have stayed off ...","65 Years","120 Years",{"count":369,"type":23},200,[238],"Background:\n\nNormal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.\n\nObjective:\n\nTo learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults.\n\nEligibility:\n\nPeople aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed.\n\nDesign:\n\nParticipants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet.\n\nParticipants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only.\n\nThose having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit.\n\nThose taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.",[64],[374,375,376],"Aging","Psilocybin","Cognitive Training","2026-08-06",{"date":150,"type":39},{"date":380,"type":23},"2026-10-01",{"date":382,"type":23},"2030-12-31",{"name":384,"class":227},"National Institute on Aging (NIA)",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":393,"targetDuration":4,"studyType":24,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":406},"100606023","phase-3-a-clinical-trial-of-trontinemab-in-participants-with-early-symptomatic-alzheimers-disease-100606023","NCT07170150","A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)","TRONTIER 2","Inclusion Criteria:\n\n* Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)\n* Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181\u002FAβ42 ratio may be used as an alternative option if amyloid PET is not available\n* Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4\n* Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0\n* Participant- and\u002For Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening\n* A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order\n* Availability of a \"study partner\" as defined by the protocol\n\nExclusion Criteria:\n\n* Any evidence of a condition other than AD that may affect cognition\n* History or presence of clinically significant cerebrovascular disease\n* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma\n* History or presence of clinically significant intracranial mass\n* MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI\n* Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments\n* History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death",{"count":394,"type":23},800,[26],"The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \\[MCI\\] to mild dementia due to AD).",[29],[31,32,33],"2026-08-04",{"date":377,"type":39},{"date":402,"type":39},"2025-11-12",{"date":404,"type":23},"2028-06-07",{"name":45,"class":46},150,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":390,"acronym":412,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":396,"conditions":415,"keywords":416,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":422},"100605979","phase-3-a-study-of-trontinemab-in-participants-with-early-symptomatic-alzheimers-disease-100605979","NCT07169578","A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease","TRONTIER 1",{"count":394,"type":23},[26],[29],[31,32,33],{"date":377,"type":39},{"date":419,"type":39},"2025-09-17",{"date":404,"type":23},{"name":45,"class":46},143,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":142,"enrollmentInfo":430,"targetDuration":4,"studyType":24,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100623633","phase-2-study-to-evaluate-the-effect-of-ht-4253-for-the-prevention-of-alzheimers-disease-in-apoe4-carriers-100623633","NCT07399171","Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers","Inclusion Criteria:\n\n1. Participant must be 50-75 years of age, without previous AD diagnosis at the time of signing the informed consent.\n2. Capable of giving signed informed consent.\n3. Body mass index (BMI) between 18 and 32 kg\u002Fm2.\n4. A positive amyloid probability score from PrecivityAD2™ test (≥ 47.5).\n5. APOE4 carrier: homozygous (APOE4\u002FAPOE4) or heterozygous (APOE3\u002FAPOE4), confirmed using the Precivity-ApoE™ test.\n6. Must be ambulatory.\n7. Must be in good health, as determined by the PI, without clinically significant medical history.\n8. Normal physical examination, 12-lead ECG, and vital signs, as determined by the PI.\n9. Females must meet one of the following:\n\n   * Postmenopausal\n   * Surgically sterile\n10. Male participants who are sexually active with a woman of childbearing potential must agree to use a double contraception during the study and for 30 days after the last dose of HT-4253.\n11. Female participants must have a negative serum pregnancy test (β-human chorionic gonadotropin \\[β-hCG\\]) at screening.\n12. Able to comply with the study procedures in the view of the PI.\n\nExclusion Criteria:\n\n1. Any medical or neurological condition that in the opinion of the PI may be supportive of dementia.\n2. A history of subjective memory decline with gradual onset and slow progression over the 6 months prior to Screening.\n3. Previous or current diagnosis of AD or mild cognitive decline: MoCA \\\u003C 26.\n4. Any clinically significant CNS, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the PI's opinion.\n5. Any condition which, in the PI's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study.\n6. History of clinically significant unstable psychiatric illness at the PI's discretion (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) Note: Well-controlled and stable major depressive disorder or anxiety is permitted.\n7. Prior treatment with an investigational LRRK2 inhibitor or any investigational AD therapy within the 6 months prior to Screening.\n8. Concomitant use of prescription medications primarily indicated for psychiatric disorders or neurodegenerative disease (e.g., antipsychotics, mood stabilizers, investigational agents) within 30 days prior to first dose of study drug (Study Day 1).\n9. Transient ischemic attack or stroke or any unexplained loss of consciousness (e.g., fainting without a diagnosis) within 1 year prior to Screening.\n10. Known cerebral or systemic vasculopathy.\n11. History of seizure or convulsion within 3 years prior to Screening or progressive neurologic disease (Parkinson's with dementia, epilepsy with breakthrough seizures, normal pressure hydrocephalus, multiple sclerosis with recent relapse).\n12. Have donated blood or had loss of blood of more than a single unit of blood within 8 weeks before Screening or intend to donate blood during the course of the study.\n13. Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months prior to first dose of study drug (Study Day 1).\n14. History of unstable angina, myocardial infarction, and\u002For chronic heart failure.\n15. Chronic, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 95 mmHg).\n16. Vaccinations within 10 days prior to Screening.\n17. Use of any medications, including prescription, over the counter (OTC) medications, vitamins, herbal preparations, and supplements, that, in the opinion of the PI, may put the participant at higher risk for AEs, or impair the participant's ability to complete study procedures.\n18. Use of other investigational drugs at the time of Screening or within 30 days or 5 half-lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations.\n19. History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco\u002Fnicotine equivalent) within 3 months of Screening or refuse to abstain from tobacco or nicotine-containing products throughout the duration of the study.\n20. History of, or current substance use disorder, including heavy alcohol use.\n21. Pregnant or breastfeeding.\n22. Presence of any laboratory abnormalities at Screening.\n23. Prolonged QT interval exclusions for QTcF \\>450 ms for males and \\>470 ms for females Note: Entry of any participant with an abnormal ECG must be approved and documented by signature of the PI or a medically qualified sub-investigator.\n24. Impaired renal function with estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2.",{"count":431,"type":23},112,[238],"Primary Objectives:\n\nTo demonstrate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, low risk APS2 score.\n\nSecondary Objectives:\n\n* To assess the effects of HT-4253 on tau related blood biomarker progression over the study period.\n* To assess the effects of HT-4253 on amyloid related blood biomarker progression over the study period.\n* To assess the safety and tolerability of HT-4253 in the UAE population.",[29],"2026-08-03",{"date":437,"type":39},"2026-08-05",{"date":439,"type":39},"2026-05-12",{"date":441,"type":23},"2028-07",{"name":443,"class":46},"Halia Therapeutics, Inc.",3,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":142,"enrollmentInfo":452,"targetDuration":4,"studyType":24,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":186},"100611004","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ro7812653-in-participants-with-early-symptomatic-alzheimers-disease-ead-100611004","NCT07234942","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease","Inclusion Criteria:\n\n* Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \\[McKhann et al 2011\\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) \\[Albert et al 2011\\]).\n* Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.\n* Fluency in the language of the tests used at the study site.\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).\n* If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.\n* Agreement not to participate in other research studies for the duration of this study.\n\nExclusion Criteria:\n\n* Any medical history or evidence of a condition other than AD that may affect cognition.\n* Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI\n* Any other significant cerebral abnormalities that the Investigator considers clinically significant\n* History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'\n* Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could affect the subject's safety in the study or interfere with the study assessments",{"count":304,"type":23},[61],"This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.",[64],{"date":457,"type":39},"2026-07-29",{"date":459,"type":39},"2026-01-27",{"date":461,"type":23},"2030-05-30",{"name":45,"class":46},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":20,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100593846","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-100593846","NCT07011745","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:\n\ni) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available:\n\nA. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status.\n\nii) Oversee participant compliance with medication and study procedures.\n\niii) Participate in the study assessments and provide informed consent to participate in the study.\n\n* History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n* AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n* Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and Visit 2.\n\nExclusion Criteria\n\n\\- Medical Conditions.\n\ni) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n\niii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy.\n\ni) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nNote: Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":471,"type":23},426,[26],"The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[64],[476,477,478,479,99],"Alzheimer's Disease (AD)","Agitation","ADAGIO","KarXT",{"date":457,"type":39},{"date":482,"type":39},"2025-07-16",{"date":484,"type":23},"2028-11-13",{"name":78,"class":46},145,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":24,"phases":497,"briefSummary":498,"conditions":499,"keywords":501,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":522},"100565847","phase-2-a-study-of-a-potential-disease-modifying-treatment-in-individuals-at-risk-for-or-with-a-type-of-early-onset-ad-caused-by-a-genetic-mutation-100565847","NCT06647498","A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation","A Phase II\u002FIII Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer's Disease","DIAN-TU-002","Inclusion Criteria:\n\n1. Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs.\n2. Participant is at least 18 years old.\n3. People of childbearing potential\n\n   1. Must have a negative serum pregnancy test at screening (V1)\n   2. Must agree not to try to become pregnant from the time of signed ICF until twenty (20) weeks after the last dose of any study drug.\n   3. Must agree not to breastfeed from the time of signed ICF until twenty (20) weeks after the last dose of any study drug.\n   4. If partner is not sterilized, must agree to use highly effective contraceptive measures, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly from screening (V1) until twenty (20) weeks after last dose of any study drug.\n\n   i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal ii. progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable iii. intra-uterine device (IUD) iv. intrauterine hormone-releasing systems (IUS) v. bilateral tubal occlusion vi. vasectomized partner (only when this is the only partner) vii. true sexual abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\], declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception)\n4. Mutation Status:\n\n   1. Participant is a carrier of a mutation in an APP, PSEN1, or PSEN2 gene that is associated with DIAD or does not know their mutation status and there is a mutation in their family pedigree that puts them at a direct risk of inheriting the known mutation;\n   2. Participant is -25 to -11 years from predicted age of cognitive symptom onset based on their mutation type or family pedigree Note: If the at-risk parent is deemed a non-carrier through confirmed genetic testing at any time during the study, the participant will be withdrawn.\n5. Cognitive status of participant is normal (CDR-SB 0).\n6. Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning. Participants must be fluent in languages for which cognitive and clinical measures have been translated and validated for use in the DIAN-TU. Fluency is generally defined as daily or frequent functional use of a language generally from birth or a young age. In cultures where multiple languages are spoken or for participants who are multilingual, determination as to whether a participant's level of fluency in languages for which clinical and cognitive measures are available meets qualification for the study should be made by the site PI.\n7. Adequate visual and auditory abilities to perform all aspects of the cognitive and clinical assessments.\n8. Receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to baseline visit (V2) with the exceptions of medications taken for episodic conditions (e.g., migraine abortive therapy, antibiotics, and other medications for upper respiratory and gastrointestinal ailments).\n9. Has a study partner who in the PI's judgment can provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at the study visits that require study partner input for scale completion, and who signs the necessary ICF, if applicable.\n10. Agrees not to donate blood or blood products for transfusion from the time of Screening (V1) for a study drug arm, for the duration of the study, and for 5 half lives after the final dose of study drug.\n11. In the opinion of the PI, the participant will be compliant and have a high probability of completing the study.\n12. Willing to complete all study-related testing, evaluations, and procedures.\n\nExclusion Criteria:\n\n1. Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the study affect cognition or the participant's ability to complete the study. This would include disorders such as: recent or severe head trauma causing cognitive change, seizure disorder, neurodegenerative disease other than DIAD, hydrocephalus, cerebral\u002Fspinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes) or endocrine disorder; psychiatric disorders such as schizophrenia, schizoaffective disorder, bipolar disorder or major depression, or any other psychiatric condition\u002Fdisorder which could significantly interfere with the participant's cooperative participation (e.g., prominent anxiety, agitation or behavioral problems).\n\n   Disorders that are controlled medically or remote history of these disorders (e.g., history of febrile seizures in childhood) that are not likely to interfere with cognitive function and compliance with study procedures are not exclusionary.\n2. At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months, current major depression (as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \\[DSM-V\\]), or increased suicide risk based on screening Columbia Suicide Severity Rating Scale (C-SSRS). Current stable mild depression or current use of antidepressant medications are not exclusionary.\n3. History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor for stroke or cerebral hemorrhage (including atrial fibrillation and anticoagulation, documented transient ischemic attack \\[TIA\\] in the last 12 months) that may be interfering with cognition or is likely to impact with the participant's ability to complete the study.\n4. Alcohol or substance use sufficient to meet DSM-V criteria currently or within the past year.\n5. History of or Baseline (V2) visit brain MRI scan indicative of any other significant abnormality, definite microhemorrhages, evidence of a cerebral contusion, encephalomalacia, or aneurysms. Minor or clinically insignificant imaging findings are not exclusionary.\n6. Presence of certain implanted medical devices, such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body which would preclude MRI scan.\n7. Cardiovascular complications such as uncontrolled hypertension, history of myocardial infarcts, heart failure, atrial fibrillation, long QT interval on ECG likely to interfere with participation in or analysis of the trial in the opinion of the investigator\n8. Hepatic or renal abnormalities that in the opinion of the investigator would interfere with participation in or analysis of the trial.\n9. History of Human Immunodeficiency Virus (HIV) infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated, history of spirochete infection (e.g., syphilis, Lyme) of the CNS or history of other infection with high risk for interfering with participation or interpretation of the study in the opinion of the investigator.\n10. History of clinically significant multiple or severe drug allergies, significant atopy, or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and\u002For exfoliative dermatitis) or sensitivity to study-drug specific PET imaging agents with a high risk for interfering with participation or interpretation of the study in the opinion of the investigator.\n11. Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within 90 days prior to Baseline (V2) visit (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.\n12. Current clinically significant abnormalities of thyroid function, or clinically significant deficiency in vitamin B12. Vitamin B12 less than the lower limits of normal with normal methylmalonic acid (MMA)\u002Fhomocysteine is not deemed clinically significant, therefore not exclusionary.\n13. Unstable or poorly controlled diabetes which the investigator believes may interfere with participation in or analysis of the study protocol. Participants may be rescreened after 3 months to allow optimization of diabetic control\n14. Morbid obesity with significant comorbidities or that would preclude MRI imaging.\n15. Current use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, or apixaban). Daily use of low dose (\\\u003C 325 mg) aspirin is not exclusionary.\n16. Have been exposed to a monoclonal antibody targeting Aβ peptide within the past 6 months or 5 half-lives from screening, whichever is longer.\n17. Received any other investigational pharmacological treatment within 3 months of Screening or 5 half-lives, whichever is longer.\n\n    Note: Use of approved treatments for AD and other medications may be permitted in this study.\n18. Lack of sufficient venous access.\n19. Clinically relevant abnormalities in hematology, coagulation, or clinical chemistry.\n20. History of cancer that the investigator believes has high risk of recurrence and impacting study participation or analysis.\n21. Any other medical condition that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk.\n22. Currently, or within the last month prior to screening, participated in a clinical study, including a nonpharmacological study, without prior approval.\n23. Participants with the \"Dutch\" APP E693Q mutation.\n24. Unable to complete baseline visit (V2) procedures with appropriate cognitive and clinical scores for eligibility\n25. A centrally read MRI demonstrating presence of ARIA-E, \\> 4 cerebral microhemorrhages, any superficial siderosis, any macrohemorrhage, or severe white matter disease at screening.\n26. Exposure to lecanemab, donanemab, or other investigational amyloid lowering agents within the past 6 months or five half-lives from screening, whichever is longer.\n27. Investigator site personnel directly affiliated with this trial and\u002For their immediate families, defined as a spouse, parent, child, or sibling, whether biological or legally adopted\n28. Lilly employees or employees of a third-party organization (TPO) involved in this study that requires exclusion of their employees or have study partners who are Lilly employees or are employees of TPOs involved in this study that require exclusion of their employees",{"count":496,"type":23},280,[238,26],"The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug.\n\nStage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD).\n\nStage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.",[29,96,500],"Alzheimers Disease, Familial",[502,64,96,503,504,505,506,507,508,509,510,511,512],"Alzheimer's","Mutation","Genetic Mutation","Dominantly Inherited Alzheimer's Disease","Dominantly Inherited Alzheimer Network","Autosomal Dominant Alzheimer's Disease","Early Onset Alzheimer's Disease","DIAN","DIAN-TU","DIAN TU","DIAD","2026-07-23",{"date":515,"type":39},"2026-07-27",{"date":517,"type":39},"2024-11-22",{"date":519,"type":23},"2034-08",{"name":521,"class":134},"Washington University School of Medicine",37,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":492,"acronym":510,"eligibilityCriteria":528,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":536,"leadSponsor":538,"locationsCount":522},"100481680","phase-2-a-study-of-potential-disease-modifying-treatments-in-individuals-at-risk-for-or-with-a-type-of-early-onset-ad-caused-by-a-genetic-mutation-100481680","NCT05552157","A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation","Inclusion Criteria:\n\n1. Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs.\n2. Participant is at least 18 years old.\n3. People of childbearing potential\n\n   1. Must have a negative serum pregnancy test at screening (V1)\n   2. Must agree not to try to become pregnant from the time of signed ICF until twenty (20) weeks after the last dose of any study drug.\n   3. Must agree not to breastfeed from the time of signed ICF until twenty (20) weeks after the last dose of any study drug.\n   4. If partner is not sterilized, must agree to use highly effective contraceptive measures, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly from screening (V1) until twenty (20) weeks after last dose of any study drug.\n\n   i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal ii. progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable iii. intra-uterine device (IUD) iv. intrauterine hormone-releasing systems (IUS) v. bilateral tubal occlusion vi. vasectomized partner (only when this is the only partner) vii. true sexual abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\], declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception)\n4. Mutation Status:\n\n   1. Participant is a carrier of a mutation in an APP, PSEN1, or PSEN2 gene that is associated with DIAD or does not know their mutation status and there is a mutation in their family pedigree that puts them at a direct risk of inheriting the known mutation;\n   2. Participant is -25 to -11 years from predicted age of cognitive symptom onset based on their mutation type or family pedigree Note: If the at-risk parent is deemed a non-carrier through confirmed genetic testing at any time during the study, the participant will be withdrawn.\n5. Cognitive status of participant is normal (CDR-SB 0).\n6. Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning. Participants must be fluent in languages for which cognitive and clinical measures have been translated and validated for use in the DIAN-TU. Fluency is generally defined as daily or frequent functional use of a language generally from birth or a young age. In cultures where multiple languages are spoken or for participants who are multilingual, determination as to whether a participant's level of fluency in languages for which clinical and cognitive measures are available meets qualification for the study should be made by the site PI.\n7. Adequate visual and auditory abilities to perform all aspects of the cognitive and clinical assessments.\n8. Receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to baseline visit (V2) with the exceptions of medications taken for episodic conditions (e.g., migraine abortive therapy, antibiotics, and other medications for upper respiratory and gastrointestinal ailments).\n9. Has a study partner who in the PI's judgment can provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at the study visits that require study partner input for scale completion, and who signs the necessary ICF, if applicable.\n10. Agrees not to donate blood or blood products for transfusion from the time of Screening (V1) for a study drug arm, for the duration of the study, and for 5 half lives after the final dose of study drug.\n11. In the opinion of the PI, the participant will be compliant and have a high probability of completing the study.\n12. Willing to complete all study-related testing, evaluations, and procedures.\n\nExclusion Criteria:\n\n1. Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the study affect cognition or the participant's ability to complete the study. This would include disorders such as: recent or severe head trauma causing cognitive change, seizure disorder, neurodegenerative disease other than DIAD, hydrocephalus, cerebral\u002Fspinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes) or endocrine disorder; psychiatric disorders such as schizophrenia, schizoaffective disorder, bipolar disorder or major depression, or any other psychiatric condition\u002Fdisorder which could significantly interfere with the participant's cooperative participation (e.g., prominent anxiety, agitation or behavioral problems).\n\n   Disorders that are controlled medically or remote history of these disorders (e.g., history of febrile seizures in childhood) that are not likely to interfere with cognitive function and compliance with study procedures are not exclusionary.\n2. At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months, current major depression (as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \\[DSM-V\\]), or increased suicide risk based on screening Columbia Suicide Severity Rating Scale (C-SSRS). Current stable mild depression or current use of antidepressant medications are not exclusionary.\n3. History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor for stroke or cerebral hemorrhage (including atrial fibrillation and anticoagulation, documented transient ischemic attack \\[TIA\\] in the last 12 months) that may be interfering with cognition or is likely to impact with the participant's ability to complete the study.\n4. Alcohol or substance use sufficient to meet DSM-V criteria currently or within the past year.\n5. History of or Baseline (V2) visit brain MRI scan indicative of any other significant abnormality, definite microhemorrhages, evidence of a cerebral contusion, encephalomalacia, or aneurysms. Minor or clinically insignificant imaging findings are not exclusionary.\n6. Presence of certain implanted medical devices, such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body which would preclude MRI scan.\n7. Cardiovascular complications such as uncontrolled hypertension, history of myocardial infarcts, heart failure, atrial fibrillation, long QT interval on ECG likely to interfere with participation in or analysis of the trial in the opinion of the investigator\n8. Hepatic or renal abnormalities that in the opinion of the investigator would interfere with participation in or analysis of the trial.\n9. History of Human Immunodeficiency Virus (HIV) infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated, history of spirochete infection (e.g., syphilis, Lyme) of the CNS or history of other infection with high risk for interfering with participation or interpretation of the study in the opinion of the investigator.\n10. History of clinically significant multiple or severe drug allergies, significant atopy, or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and\u002For exfoliative dermatitis) or sensitivity to study-drug specific PET imaging agents with a high risk for interfering with participation or interpretation of the study in the opinion of the investigator.\n11. Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within 90 days prior to Baseline (V2) visit (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.\n12. Current clinically significant abnormalities of thyroid function, or clinically significant deficiency in vitamin B12. Vitamin B12 less than the lower limits of normal with normal methylmalonic acid (MMA)\u002Fhomocysteine is not deemed clinically significant, therefore not exclusionary.\n13. Unstable or poorly controlled diabetes which the investigator believes may interfere with participation in or analysis of the study protocol. Participants may be rescreened after 3 months to allow optimization of diabetic control\n14. Morbid obesity with significant comorbidities or that would preclude MRI imaging.\n15. Current use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, or apixaban). Daily use of low dose (\\\u003C 325 mg) aspirin is not exclusionary.\n16. Have been exposed to a monoclonal antibody targeting Aβ peptide within the past 6 months or 5 half-lives from screening, whichever is longer.\n17. Received any other investigational pharmacological treatment within 3 months of Screening or 5 half-lives, whichever is longer.\n\n    Note: Use of approved treatments for AD and other medications may be permitted in this study.\n18. Lack of sufficient venous access.\n19. Clinically relevant abnormalities in hematology, coagulation, or clinical chemistry.\n20. History of cancer that the investigator believes has high risk of recurrence and impacting study participation or analysis.\n21. Any other medical condition that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk.\n22. Currently, or within the last month prior to screening, participated in a clinical study, including a nonpharmacological study, without prior approval.\n23. Participants with the \"Dutch\" APP E693Q mutation.\n24. Unable to complete baseline visit (V2) procedures with appropriate cognitive and clinical scores for eligibility",{"count":496,"type":23},[238,26],"The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction\u002Fprevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.",[29,96,500],[502,64,96,503,504,505,506,507,508,509,510,511,512],{"date":515,"type":39},{"date":517,"type":39},{"date":537,"type":23},"2034-08-30",{"name":521,"class":134},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":282,"phases":4,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":4},"100648414","a-retrospective-database-study-for-the-development-and-validation-of-algorithms-for-intracerebral-hemorrhage-and-seizures-in-alzheimers-disease-100648414","NCT07723950","A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease","Development and Validation of Algorithms for Identifying Intracerebral Hemorrhage and Seizures in Patients With Alzheimer's Disease: A Retrospective Database Study Using United States Healthcare Administrative Claims Data","Inclusion Criteria:\n\n* Before or on the outcome event date, have at least 1 ICD-10-CM diagnosis code for AD in medical claims in an inpatient setting; or have at least 2 ICD-10-CM diagnosis codes in medical claims in an outpatient setting, at least 7 days and less than 365 days apart\n* Have at least 365 days of continuous coverage with medical and pharmacy benefits before the outcome event date\n* Have EHR data available for (1) the outcome event date or (2) during the period of up to 30 days before and up to 90 days after the outcome event date\n* Have unstructured EHR information (ie, clinical notes) available for any encounter (1) on the outcome event date or (2) during the period of 30 days before to up to 45 days after the outcome event date\n\nExclusion Criteria:\n\n* New-onset seizure outcome only: Have any ICD-10-CM diagnosis code for seizure or epilepsy before the outcome event date",{"count":547,"type":23},600,"The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage \\>1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and hemosiderin deposit (ARIA-H; microhemorrhage, superficial siderosis) in participants with Alzheimer's disease (AD) using claims data in the United States (US) with linkage to electronic health records (EHRs), and to estimate the positive predictive values (PPVs) of the algorithms. The secondary objective of the study is to validate claims-based algorithms to identify new-onset seizures in participants with AD using US claims data with linkage to EHRs and to estimate the PPVs of the algorithms.",[64],[64,551,552,553],"Intracerebral Hemorrhage","Seizures","US Healthcare Claims Data","2026-07-20",{"date":513,"type":39},{"date":557,"type":23},"2026-07-30",{"date":559,"type":23},"2026-12-31",{"name":271,"class":46},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":161,"maxAge":57,"enrollmentInfo":569,"targetDuration":4,"studyType":24,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100648175","phase-3-a-study-of-trontinemab-in-cognitively-unimpaired-individuals-at-risk-for-progression-to-symptomatic-alzheimers-disease-100648175","NCT07717411","A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease","PrevenTRON","Inclusion Criteria:\n\n* Body weight of 150 kg or less\n* Willingness and ability to complete all aspects of the study for the duration of the study\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)\n* Cognitively and functionally unimpaired as defined by the protocol\n* Availability of a study partner as defined by the protocol\n* A plasma pTau217 level consistent with a high likelihood of future clinical progression\n\nExclusion Criteria:\n\n* Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia\n* Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia\n* History or presence of clinically significant cerebrovascular disease\n* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma\n* History or presence of clinically significant intracranial mass\n* History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder\n* History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack\n* At risk for suicide in the opinion of the investigator\n* Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)\n* Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments\n* Uncontrolled hypertension\n* Impaired hepatic function\n* History or presence of any clinically significant hematological diseases\n* Diagnosis of a wet age-related macular degeneration (AMD)\n* Abnormal thyroid function\n* Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and\u002For may impact cognition as per the investigator's judgment\n* Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator\n* History of malignancy\n* Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline\n* Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline\n* Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer\n* Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer\n* Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization\n* Any treatment with cholinesterase inhibitors\n* Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication\n* Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline\n* Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments\n* Residence in a skilled nursing facility such as a convalescent home or long-term care facility",{"count":570,"type":23},1600,[26],"This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.",[64],[502,64,575],"pre-clinical","2026-07-17",{"date":578,"type":39},"2026-07-21",{"date":580,"type":23},"2026-11-30",{"date":582,"type":23},"2032-09-03",{"name":45,"class":46},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":509,"eligibilityCriteria":589,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":282,"phases":4,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100123128","dominantly-inherited-alzheimer-network-dian-100123128","NCT00869817","Dominantly Inherited Alzheimer Network (DIAN)","Inclusion Criteria:\n\n* Written informed consent obtained from participant and collateral source prior to any study-related procedures.\n* Aged 18 (inclusive) or older and the child of an affected individual (clinically or by testing) in a pedigree with a known mutation for ADAD.\n* Cognitively normal to very mild or mild cognitive impairment (CDR score range 0-1.0). Primary enrollment will focus on the recruitment of asymptomatic adult children who are more than 15 years younger than the estimated age of symptom onset. Enrollment of new participants with moderate cognitive impairment is allowed with the prior approval of the DIAN Coordinating Center.\n* Has two persons who are not their full-blooded siblings who can serve as collateral sources for the study.\n* Fluent in a language approved by the DIAN Coordinating Center at about the 6th grade level (international equivalent) or above.\n\nExclusion Criteria:\n\n* Under age 18\n* Medical or psychiatric illness that would interfere in completing initial and follow-up visits\n* Requires nursing home level care\n* Has no one who can serve as a study informant",{"count":591,"type":23},700,"The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.",[64],[123,595,596,597,598,507],"antecedent biomarkers","Amyloid Precursor Protein (APP) mutation","presenilin I (PS1) mutation","presenilin 2 (PS2) mutation","2026-07-16",{"date":554,"type":39},{"date":602,"type":4},"2009-01",{"date":604,"type":23},"2026-09",{"name":521,"class":134},26]