[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimer-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimer-disease":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,368,0,25,[9,52,73,102,133,164,191,215,241,265,293,316,336,355,387,407,433,453,470,498,519,543,566,583,602],{"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":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100605160","phase-1-av-1980r-tau-vaccine-in-preclinical-alzheimers-disease-taurus-1980-100605160",false,"NCT07158905","AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)","A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease","TAURUS-1980","Inclusion Criteria:\n\nMale or postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive.\n\nCognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following:\n\nClinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening.\n\nPlasma p-tau217\u002FAβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory.\n\nSight and hearing, including use of a hearing aid, sufficient to comply with study procedures.\n\nStable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled.\n\nSigned informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements.\n\nExclusion Criteria:\n\nScreening MRI showing any of the following:\n\nMore than one noncortical lacunar infarct greater than 1.5 cm. Any territorial infarct greater than 1.5 cm. Combined microbleeds and areas of leptomeningeal hemosiderosis greater than 5, or disseminated leptomeningeal hemosiderosis.\n\nAny other significant cerebral abnormality, including ARIA-E. Contraindication to MRI, including non-MRI-safe implanted metallic devices or clinically significant claustrophobia.\n\nSerious illness requiring systemic treatment or hospitalization within 4 weeks before study entry.\n\nClinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, systemic disease, or major surgery that could interfere with participation or follow-up.\n\nInsulin-dependent diabetes. Clinically relevant cardiac arrhythmia, palpitation, conduction abnormality, prolonged QT interval, or bundle branch block.\n\nPre-existing autoimmune disease. C-SSRS score of 3 or higher. History of seizure disorder, except permitted stable use of certain antiepileptic medications for chronic pain.\n\nAny medical, psychological, or social condition that could interfere with participation, compliance, or participant safety.\n\nParticipation in another investigational drug study or use of an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.\n\nPrior tau or amyloid-beta immunotherapy within 1 year before Screening. Use of specified immunomodulatory or growth-stimulating treatments within 30 days before study entry.\n\nChronic use for more than 3 months of warfarin, other coumarin derivatives, anticoagulants, or an antiplatelet agent such as clopidogrel.\n\nParenteral immunoglobulin preparations, blood products, or plasma derivatives. History of severe local or systemic vaccination reactions or significant allergic reactions.\n\nClinically significant laboratory abnormalities at Screening, including ALT or AST greater than 1.5 times the upper limit of normal.\n\nPositive testing for HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C.","ALL","65 Years","80 Years",{"count":22,"type":23},48,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.",[29,30],"Alzheimer Disease","Preclinical Alzheimer's Disease",[32,33,34,30,35,36,37,38],"Tau protein","Immunotherapy","Vaccine","Alzheimer's Disease","secondary prevention","Neurodegeneration","Preventive Alzheimer's","RECRUITING","2026-08-20",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2026-06-23",{"date":47,"type":23},"2029-10-15",{"name":49,"class":50},"Institute for Molecular Medicine","OTHER",6,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100595379","effects-and-mechanisms-of-temporal-interference-brain-stimulation-on-memory-function-in-preclinical-alzheimers-disease-100595379","NCT07031687","Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease","Inclusion Criteria:\n\n* Individuals recruited from neurology memory clinics or communities.\n* Age between 60 and 80 years old, inclusive; no gender limitation.\n* Right-handed.\n* Cognitive function test results within normal range after age, gender, and education-level adjustment, OR mild cognitive impairment not yet meeting diagnostic criteria for Mild Cognitive Impairment (MCI), OR only subjective cognitive decline.\n* Individuals classified as preclinical AD based on the revised 2024 AD diagnostic and staging criteria (i.e., cognitively normal with positive plasma p-tau217 or positive Aβ PET).\n* Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Past or present neurological diseases (e.g., stroke, epilepsy, Parkinson's disease, multiple sclerosis).\n* Psychiatric disorders such as severe depression or severe anxiety.\n* Systemic diseases causing cognitive decline (e.g., severe thyroid dysfunction, severe liver or kidney disease, severe nutritional deficiencies).\n* Currently taking medications that may affect cognitive function (e.g., anticholinergics, benzodiazepines, antipsychotics) that cannot be discontinued or adjusted.\n* Other factors leading to cognitive decline that are not AD-related.\n* Contraindications for MRI scans, such as claustrophobia, implanted metallic devices (e.g., pacemakers, cochlear implants, aneurysm clips), or history of head injury with retained metal fragments.","60 Years",{"count":60,"type":23},1200,[62],"NA","The goal of this clinical trial is to learn if personalized, multimodal imaging-guided, EEG-based closed-loop Temporal Interference Brain Stimulation (TIBS) can improve memory function in individuals with preclinical Alzheimer's Disease (AD).\n\nThe main questions it aims to answer are:\n\n1. Does personalized TIBS lead to significant changes in functional connectivity strength of hippocampal-cortical networks at the end of the 2-week intervention compared to baseline?\n2. What are the short-term (end of 2-week intervention) and medium-to-long-term (4 weeks and 12 weeks post-intervention) effects of personalized TIBS on episodic and working memory, as well as other cognitive domains in preclinical AD?\n3. How does personalized TIBS modulate brain activity and connectivity, as measured by EEG power spectra and functional MRI (fMRI) functional connectivity, in preclinical AD?\n4. What is the safety profile of personalized TIBS in this population?\n\nResearchers will compare participants receiving active personalized TIBS to participants receiving sham (inactive) stimulation to see if TIBS effectively improves memory function and induces neural plasticity.\n\nParticipants will:\n\n1. Undergo initial screening including neuropsychological assessments and blood p-tau217 testing to identify preclinical AD.\n2. Receive either active personalized TIBS or sham stimulation daily for 40 minutes, 6 days a week, for 2 weeks.\n3. Have individualized TIBS parameters (e.g., target localization, intensity) determined using baseline structural MRI and DTI.\n4. Undergo real-time high-density EEG monitoring during daily stimulation sessions to enable closed-loop adjustment of stimulation parameters.\n5. Participate in follow-up assessments at the end of the 2-week intervention, and at 4 weeks and 12 weeks post-intervention.\n6. Receive multimodal imaging (sMRI, rs-fMRI, task-fMRI, DTI) and blood biomarker assessments at various time points.\n7. Receive Aβ-PET and tau-PET scans, along with comprehensive neuropsychological assessments, at the 12-week follow-up.\n8. Have their safety continuously monitored throughout the study.",[29],{"date":42,"type":43},{"date":67,"type":43},"2025-07-01",{"date":69,"type":23},"2029-12-31",{"name":71,"class":50},"Xuanwu Hospital, Beijing",2,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":20,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100581208","phase-2-study-of-lhp588-in-subjects-with-p-gingivalis-positive-alzheimers-disease-100581208","NCT06847321","Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease","Inclusion Criteria:\n\n* AD according to the National Institute on Aging-Alzheimer's Association criteria.\n* MMSE scores corresponding to mild and moderate AD.\n* Saliva rinse sample positive for P. gingivalis.\n* Plasma pTau217 above cutoff.\n* Subject and caregiver have provided full written informed consent.\n* Background symptomatic therapy with acetylcholinesterase inhibitors, and\u002For memantine, are allowed if the dose has been stable for 90 days and no changes are planned during the study.\n* Modified Hachinski score ≤4 at screening.\n\nExclusion Criteria:\n\n* History of cancer requiring systemic therapy in last 5 years.\n* Evidence of a clinically significant, unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within 6 months prior to screening.\n* Unstable angina, uncompensated and\u002For symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.\n* Acute or poorly controlled blood pressure \\>180 mmHg systolic or \\>100 mmHg diastolic at screening visit.\n* History or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's Disease, other.\n* Currently being treated with anti-amyloid beta antibodies or other disease-modifying treatments for dementia.\n* Other criteria in the Investigator's judgement that may interfere with the ability to participate in the study.","55 Years",{"count":82,"type":23},300,[84],"PHASE2","This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.",[29,87],"Alzheimer Disease Due to P. Gingivalis",[89,90,91],"placebo-controlled","p. gingivalis","Alzheimer disease","2026-08-19",{"date":42,"type":43},{"date":95,"type":43},"2025-02-17",{"date":97,"type":23},"2029-03-15",{"name":99,"class":100},"Lighthouse Pharmaceuticals, Inc.","INDUSTRY",40,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100510405","efficacy-of-rgn600-in-patients-with-mild-to-moderate-alzheimers-disease-100510405","NCT05926011","Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease","Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)","LIGHT4LIFE","Inclusion Criteria:\n\n* Male or female aged 55 to 85 years old (both included)\n* Diagnosed with AD according to McKhann et al. international criteria dated 2011\n* With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26\n* With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including calcium, creatinine, clearance, alanine aminotransferase, aspartate aminotransferase, bilirubin, coagulation, C-reactive protein) dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator\n* With brain Computed Tomography (CT) or\u002Fand Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator\n* In case of treatment with AD symptomatic treatments (memantine and acetylcholinesterase inhibitors) and psychotropic treatments (anxiolytics, antidepressants and neuroleptics): with a stable dose of such treatments 4 weeks before inclusion\n* Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator\n* Affiliated to French social security\n* Who provided, with his\u002Fher caregiver, a dated and signed informed consent form.\n\nExclusion Criteria:\n\n* Patient protected by a French legal measure (\"sauvegarde de justice\", \"tutelle\" or \"curatelle\")\n* Patient deprived of liberty or hospitalized without consent\n* Non-menopausal woman\n* Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before the end of the study\n* Patient living in a medical facility\n* Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion\n* Patient with skin lesions on the treatment application area (abdomen or head)\n* Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)\n* Patient diagnosed with a stroke within 3 months prior inclusion\n* Patients with ferromagnetic material (i.e., iron, nickel, cobalt or any metal alloy) on or near the head or abdomen, or implanted with a pacemaker\n* Patient with a risk of epileptic seizure\n* Patient with a genetic form of AD\n* Patient with major physical or neurosensorial disorders that may interfere with neurological assessments\n* Patient with chronic psychosis or psychotic episodes\n* Patient addicted to alcohol or drugs\n* Patient with known and non-supplemented vitamin B12 and folic acid deficiencies\n* Patient with known untreated hypothyroidism\n* Patient who participated to another investigation\u002Fstudy involving the use of an investigational medical device\u002Fdrug within the 30 days prior inclusion\n* Patient not able to meet treatment sessions as deemed by the investigator\n* Patient not able to complete requested investigation assessments as deemed by the investigator.","85 Years",{"count":112,"type":23},108,[62],"This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt). It combines 2 technologies:\n\n* PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs)\n* Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field.\n\nConsidering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.",[29],[117,118,119,120,121,122,123,124],"Alzheimer","Neurostimulation","Optics and photonics","Photobiomodulation","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medical Device",{"date":42,"type":43},{"date":127,"type":43},"2023-07-24",{"date":129,"type":23},"2027-12",{"name":131,"class":100},"REGEnLIFE SAS",7,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":144,"conditions":145,"keywords":152,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100388301","enhancing-outcomes-in-cognitive-impairment-through-use-of-home-sleep-apnea-testing-100388301","NCT04335994","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)","ENCHANT","Inclusion Criteria:\n\n* Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤281.\n* A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies); and\u002For (vi) Mixed disease\n* Have the competency to provide informed consent, or the availability of a substitute decision maker\u002Fcaregiver who can provide consent (if needed).\n* The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed.\n\nExclusion Criteria:\n\n* Prior diagnosis of OSA within the last 2 years\n* Patients already using CPAP or a dental appliance for previously diagnosed OSA.\n* A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT).\n* Any medical device that would interfere with the placement of the HSAT\n* Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.",{"count":142,"type":23},200,[62],"Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI\u002FAD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI\u002FAD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI\u002FAD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.",[146,29,147,148,149,150,151],"Obstructive Sleep Apnea","Vascular Dementia","Mild Cognitive Impairment","Parkinsons Disease With Dementia","Dementia With Lewy Bodies","Mixed Dementia",[146,153,154,155],"Cognitive Impairment","Home Sleep Apnea Test","Screening",{"date":40,"type":43},{"date":158,"type":43},"2019-09-23",{"date":160,"type":23},"2027-06",{"name":162,"class":50},"Sunnybrook Health Sciences Centre",1,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100588118","phase-3-a-study-to-evaluate-the-long-term-efficacy-and-safety-of-karxt--karx-ec-for-agitation-in-alzheimers-disease-adagio-3-100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","90 Years",{"count":173,"type":23},650,[175],"PHASE3","The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[29,178],"Agitation",[178,91,180,181],"KarXT","KarX-EC","2026-08-18",{"date":92,"type":43},{"date":185,"type":43},"2025-12-02",{"date":187,"type":23},"2029-07-20",{"name":189,"class":100},"Bristol-Myers Squibb",256,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":163},"100556299","presence-of-anti-rach-antibodies-and-neurocognitive-disorder-in-myasthenic-or-alzheimerss-patients-100556299","NCT06523296","Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.","Study of the Relationship Between the Presence of Anti-AChR Antibodies in the Cerebrospinal Fluid and the Presence of Neurocognitive Disorder in Myasthenic and Alzheimers's Patients.","ARN-MA","Inclusion criteria\n\nFor patient with myasthenia :\n\n1. adult person,\n2. Diagnosis of anti-AChR positive autoimmune myasthenia gravis, confirmed by clinical and biological data, and categorized in class I to IV according to the Myasthenia Gravis Foundation of America (MGFA) classification,\n3. Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,\n4. Agreeing to sign the free and informed consent,\n5. Affiliate or beneficiary of a social security system.\n\nFor patient with Alzheimer Disease :\n\n1. adult person,\n2. Mild or major neurocognitive disorder (DSM-5 criterion) having benefited from a diagnosis at the CMRR with CSF biomarker dosage and agreement to bio-collect residual CSF,\n3. Neurocognitive disorder only linked to Alzheimer's disease (IWG-2 criterion): typical or atypical clinical form with biomarkers of Alzheimer's disease in the CSF;\n4. Agreeing to sign the free and informed consent,\n5. Affiliate or beneficiary of a social security system.\n\nFor healty control :\n\n1. absence of memory complaint,\n2. absence of neurocognitive disorder,\n3. Having agreed to carry out analyzes as part of research, on these CSF samples stored in the biobank of the Institute of Translational Neurology in Münster (Germany)\n\nExclusion Criteria:\n\nFor patient with myasthenia :\n\n1. Person who does not have sufficient command of the French language to understand, read and write, to take neuropsychological tests;\n2. Need to use the routine complementary CSF tube to carry out additional diagnostic explorations as part of routine care,\n3. Vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research\u002FAdults who are subject to a legal protection measure or who are unable to express their consent.),\n\nFor patient with Alzheimer Disease :\n\n1\\) vulnerable people are defined in articles L1121-5 to -8 ( Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research\u002FAdults who are subject to a legal protection measure or who are unable to express their consent.)","18 Years",{"count":201,"type":23},30,[62],"The purpose of the study is to evaluate if there is a specific association between the presence of anti Rach antibodies in the CSF and the presence of a cogntive disorder in myasthenic patients. Moreover the investigator wants to study if there is a link between the presence of Anti RACH antibodies in myasthenia and Alzheimers's disease.\n\nFor that, the investigator will recruit myasthenic patient with cognitive disorder that has undergo a diagnostic process including lombar punction for memory trouble in Nice memory center as well as Alzheimer's patient having go through the same process.\n\nThe study will consist in one additionnal blood draw. Anti RACH antibodies will be analyzed in historical CSF stored in biocollection and serum collected for the study.\n\nLCS of healthy control will also be analyzed.",[29,205],"Myasthenia",[207,205,35,208],"Anti-RACH antibodies","neurocognitve disorder",{"date":92,"type":43},{"date":182,"type":43},{"date":212,"type":23},"2028-09-18",{"name":214,"class":50},"Centre Hospitalier Universitaire de Nice",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":110,"enrollmentInfo":222,"targetDuration":4,"studyType":224,"phases":4,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":163},"100651963","the-effect-of-sequential-therapy-on-alzheimers-disease-100651963","NCT07768579","The Effect of Sequential Therapy on Alzheimer's Disease","The Effect of Sequential Therapy on Alzheimer's Disease: A Prospective Cohort Study","Inclusion Criteria:\n\n* Age 55 to 85 years, regardless of sex.\n* Memory decline reported by the participant or family member for at least 6 months.\n* Meets the diagnostic criteria for the target disease and is clinically diagnosed with mild cognitive impairment due to Alzheimer's disease or mild, moderate, or severe Alzheimer's dementia.\n* Able to complete clinical scale assessments and blood sampling.\n* Able to undergo brain magnetic resonance imaging (MRI) or amyloid-beta positron emission tomography (Aβ-PET) examinations using the tracers specified in the study protocol.\n* Written informed consent provided by the participant or a legally authorized representative.\n* Able to complete study follow-up.\n* Participants with a known allergy to components of the exposure medications will be assigned to the non-exposed group.\n\nExclusion Criteria:\n\n* Cerebrovascular disease, traumatic brain injury, thyroid dysfunction, vitamin deficiency, or other diseases sufficient to cause cognitive impairment.\n* Malignant tumors unrelated to the target disease, hematological diseases, severe psychiatric disorders, depression, or anxiety disorders.\n* Severe dysfunction of major organs, including the heart, brain, liver, or kidneys.\n* Infectious diseases, including HIV or HBV infection.\n* Pregnancy, breastfeeding, or plans for pregnancy in the near future.\n* Gastrointestinal diseases that may affect drug absorption.\n* Use of medications affecting cognitive function within 4 weeks before enrollment.\n* Recent participation in or current participation in another trial.",{"count":223,"type":23},600,"OBSERVATIONAL","The goal of this observational study is to learn how Alzheimer's disease changes over time in people at different stages of the disease. It will look at changes in memory and thinking, daily activities, behavior, and traditional Chinese medicine symptom patterns. It will also learn about the outcomes and safety of sequential traditional Chinese medicine treatment based on the stage of Alzheimer's disease. The main questions this study aims to answer are:\n\n* How do memory and thinking, daily activities, behavior, and traditional Chinese medicine symptom patterns naturally change over time in participants with early-, middle-, and late-stage Alzheimer's disease?\n* How do symptoms and traditional Chinese medicine symptom patterns change together as Alzheimer's disease progresses?\n* Do participants receiving stage-based sequential traditional Chinese medicine treatment have different changes in memory and thinking, daily activities, behavior, and overall disease status?\n* What medical problems or side effects occur during sequential traditional Chinese medicine treatment?\n\nAbout 600 participants aged 55 to 85 years will take part in this study. Participants will be followed for 12 months.\n\nParticipants will:\n\n* Visit the study center at the start of the study and at 3, 6, 9, and 12 months.\n* Complete assessments of memory and thinking, daily activities, behavior, overall disease status, and traditional Chinese medicine symptoms.\n* Have blood tests and other study examinations.\n* Have their treatment use and medical problems recorded during follow-up.",[227,29],"Mild Cognitive Impairment Due to Alzheimer Disease",[229,230,29,227,231,232],"Sequential Therapy","Traditional Chinese Medicine","Cognitive Function","Traditional Chinese Medicine Syndrome","2026-08-17",{"date":92,"type":43},{"date":236,"type":43},"2026-04-30",{"date":238,"type":23},"2028-12-31",{"name":240,"class":50},"Dongzhimen Hospital, Beijing",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":249,"sex":18,"minAge":80,"maxAge":110,"enrollmentInfo":250,"targetDuration":4,"studyType":24,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":263,"locationsCount":72},"100424234","phase-2-senicapoc-in-alzheimers-disease-100424234","NCT04804241","Senicapoc in Alzheimer's Disease","Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimer's Disease","Senicapoc","Inclusion Criteria:\n\n* Age 55-85\n* Fluent in either English or Spanish\n* Willing to be randomized to active drug (10 mg Senicapoc) vs. placebo (3:1 ratio)\n* Clinical Dementia Rating (CDR) global score of 1 or 0.5\n* Education adjusted scores between 12-28 on the Montreal Cognitive Assessment (MoCA) at the Screening visit.\n* A consensus clinical diagnosis of either amnestic Mild Cognitive Impairment (MCI) or mild AD dementia. Diagnoses are made by a comprehensive case conference review for all participants in the ADRC longitudinal cohort and all CADC referrals, resulting in a consensus diagnosis made according to current research criteria. For patients referred from other clinics, the case will be reviewed by a study physician and neuropsychologist and only patients who satisfy criteria for probable AD (McKhann et al 1984) or amnestic MCI (Petersen et al 2004) will be eligible for enrollment.\n* Vision (with or without correction) of at least 20\u002F50 for distant vision\n* All participants will need a study partner informant who has at least 6 hours of contact per week with the participant. The study partners are used to help answer questions on the subject's behalf, since many of them will be impaired and may need assistance with providing accurate information. The study partners are not asked to provide any opinions or judgements about the subjects.\n* For Females of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the Week 78 follow up visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of less than 1% per year when used correctly and consistently.\n\nExclusion Criteria:\n\n* Unstable medical illnesses including hepatic insufficiency (elevated ALT, AST, or GGT; or low albumin attributable to liver disease), renal insufficiency (CK-EPI stage 4 or higher, or estimated GFR \\\u003C30)\n* Unstable ischemic cardiovascular disease, respiratory failure, moderate or severe congestive heart failure - New York Heart Association class III or IV, cancer, unstable hematologic disease or a life expectancy of \\\u003C3 years\n* Use of experimental AD treatments\n* Unable to undergo MRI scanning (e.g. pacemaker, metallic implants, severe claustrophobia)\n* History of chronic psychiatric illness (e.g. schizophrenia), any episode of major depression within last 2 years, or current Geriatric Depression Scale (GDS) \\> 6, any recent suicide attempts or suicidal ideation. Subjects with a diagnosis of bipolar disorder may be included if they have been clinically stable for a minimum of 3 years prior to the Screening visit. Clinical stability to be determined by the Principal Investigator.\n* History of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis), head trauma resulting in any persistent cognitive deficit\n* History of alcohol or drug abuse\u002Fdependence within the past 5 years\n* Known allergy to chemically related compounds (e.g. clotrimazole)\n* Lack of good venous access, such that multiple blood draws would be precluded\n* Regular use of any of these CNS active medications: benzodiazepines, antipsychotics, narcotics, or anti-epileptic drugs. Exceptions may be allowed by the Principal Investigator for regular use of low doses of CNS active medications. Subjects using any of these treatments will be instructed to hold their dose on the evening prior and the day of the efficacy visits (Baseline, Week 26 and Week 52). Stable doses (\\> 6 weeks) of cholinesterase inhibitors or memantine will be allowed, as will stable doses of anti-depressants.\n* Female subjects who are pregnant or breastfeeding or who plan to become pregnant during participation in this trial\n* Inability to swallow oral tablets\n\nExclusions for Cerebrospinal Fluid (CSF) Sub-study:\n\n* Presence of an implanted shunt for the drainage of CSF or an implanted CNS catheter\n* History of bleeding diathesis or coagulopathy,\n* On anticoagulant therapy (within 14 days of lumbar puncture (LP), including but not limited to warfarin, heparin, dabigatran, rivaroxaban, and apixaban,\n* Requires daily antiplatelet therapy, including but not limited to aspirin (unless \\\u003C 81mg\u002Fday), clopidogrel, dipyridamole, and ticlopiidinegrel. However, the investigators will not exclude those who can safely hold antiplatelet therapy for 7 days prior to LP. Safety will be determined by the participant's Primary Care Provider and study PI.\n* For those who take antiplatelet therapy intermittently (e.g. aspirin as needed for pain), the investigators will exclude any doses within 48 hours of the LP or more than two dosses within 7 days of LP.\n* platelet count less than the lower limit of normal (platelet counts between 100,000 and 150,000 mm3 are permissible as long as the investigator confirms there is no evidence of current bleeding diathesis or coagulopathy)\n* The investigators will require INR\u002FPT and aPTT labs to be done within 14 days of LP and will exclude those with INR \\> 1.30 or abnormally elevated aPTT.\n\nExclusions for PET Sub-Study:\n\n* Does not have good venous access, such that multiple blood draws would be precluded\n* Prior radiation exposure of \\> 2 rem total within last 12 months.\n* Probable AD dementia patients with a global cortical SUVr \\\u003C 1.08.",true,{"count":251,"type":23},55,[84],"Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD. This will be a small Proof of Mechanism study to prove biological activity and target engagement in humans with early AD. The investigators will study up to 55 patients over 52 weeks, with primary outcomes being Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) scores and blood and cerebrospinal fluid (CSF) markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy.",[148,29],[256,257,247],"Amnestic Mild Cognitive Impairment (MCI)","Mild AD dementia","2026-08-14",{"date":233,"type":43},{"date":261,"type":43},"2022-03-18",{"date":129,"type":23},{"name":264,"class":50},"University of California, Davis",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":249,"sex":18,"minAge":199,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":224,"phases":4,"briefSummary":275,"conditions":276,"keywords":283,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":163},"100651643","establishing-normal-cognitive-test-scores-for-adults-using-a-voice-enabled-digital-testing-platform-across-the-lifespan-100651643","NCT07763392","Establishing Normal Cognitive Test Scores for Adults Using a Voice-Enabled Digital Testing Platform Across the Lifespan","Establishment of Age-, Sex-, and Education-Stratified Normative Data for a Fully Digital Voice-Recognized Neurocognitive Testing Platform in Adults Aged 18-100 Years","Inclusion Criteria:\n\n* Adults aged 18 to 100 years at the time of enrollment.\n* Able to read, speak, and understand English sufficiently to complete all study procedures.\n* Able and willing to provide informed consent.\n* Adequate hearing, speech, and vision (with corrective devices if needed) to complete computerized voice-recognition cognitive testing.\n* Able to independently complete the digital cognitive assessment using a computer, tablet, or smartphone with internet access (or at a supervised study site if applicable).\n\nExclusion Criteria:\n\n* Known Cognitive Impairment Self-reported or previously diagnosed cognitive impairment, memory disorder, mild cognitive impairment, or dementia.\n* Neurological Disease or Brain Injury History of a neurological condition or brain injury that, in the opinion of the investigator, may adversely affect cognitive performance.\n* Psychiatric Illness Current or untreated psychiatric illness that may significantly influence cognitive testing performance.\n* Substance Use or Cognitive-Impacting Medications Current use of substances or medications known to significantly impair cognition or recent substance use that could affect test validity.\n* Sensory or Communication Limitations Inadequate English proficiency or speech, hearing, or visual impairments that would prevent valid completion of the digital cognitive assessment.\n* Functional or Medical Conditions Affecting Cognition Medical conditions or functional impairments that, in the opinion of the investigator, may interfere with accurate assessment of normal cognitive performance.\n* Investigator Discretion Any other condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety, study compliance, or the validity of the normative dataset.","100 Years",{"count":274,"type":23},1000,"Trial weblink: https:\u002F\u002Fwww.memoryexam.com\u002Fjob\u002Fnorms\u002F\n\nParticipants enrolled in this study will complete a single-session, non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the study is to establish normative cognitive performance data from healthy adults aged 18-100 years and develop age-, sex-, and education-adjusted reference values for the digital assessment platform. This is an observational study and does not involve any therapeutic intervention, investigational treatment, or alteration of routine medical care.\n\nFollowing electronic informed consent, participants will complete a standardized screening questionnaire to determine eligibility. The questionnaire collects demographic information, education, English language proficiency, medical and neurological history, psychiatric history, medication use, substance use, sleep history, and self-reported cognitive concerns. Standardized mood screening instruments (PHQ-9 and GAD-7) are also administered. Individuals meeting predefined exclusion criteria that could significantly influence cognitive performance will not be included in the normative dataset.\n\nEligible participants will then complete a digital cognitive assessment battery using standardized visual and auditory instructions. The platform utilizes automated voice-recognition technology to capture spoken responses and standardized algorithms to score performance, eliminating the need for examiner scoring and ensuring consistent administration across participants. Total study participation, including consent, screening, and testing, is approximately 30 to 45 minutes.\n\nThe cognitive battery evaluates multiple cognitive domains commonly assessed during neuropsychological examinations. Language abilities are assessed through phonemic and semantic verbal fluency tasks, measuring the ability to rapidly generate words within specified categories. Confrontation naming is evaluated using digitally presented images that participants identify verbally. Learning and memory are assessed through immediate and delayed verbal recall tasks, including recognition memory measures. Attention and working memory are evaluated using forward and backward digit span tasks. Executive functioning and attention are further assessed using a brief computerized problem-solving task. Equivalent alternate versions of selected tasks may be administered to minimize practice effects while measuring the same cognitive domains. All assessments are brief, non-invasive, and completed using spoken responses.\n\nThe platform automatically records participant responses, response timing, and scoring metrics. Voice recordings are collected solely to support automated scoring and quality assurance. All electronic data are transmitted using encrypted connections and stored within HIPAA-aligned cloud infrastructure. Personally identifiable information is stored separately from cognitive performance data using unique study identification numbers, and only authorized study personnel have access to identifiable information. De-identified data will be used to generate normative reference values.\n\nA subset of approximately 100 participants may be invited to complete a second assessment 2-4 weeks after the initial visit to evaluate test-retest reliability. Participation in this follow-up assessment is voluntary.\n\nParticipants will not receive diagnostic results or individualized interpretations of their performance because the study is intended solely to establish normative reference data. If responses on the PHQ-9 suggest potential acute self-harm risk, the platform will provide crisis resources and notify the study team in accordance with the study safety procedures.\n\nThe primary outcome of the study is the development of age-, sex-, and education-adjusted normative reference values for the digital cognitive assessment platform, supporting standardized interpretation of future assessments in clinical and research settings.",[277,278,279,280,29,281,282],"Cognition","Cognition Disorders","Cognition - Other","Dementia","Memory","Neurocognition",[281,277,280,35,284],"Normal","2026-08-13",{"date":233,"type":43},{"date":288,"type":43},"2026-03-23",{"date":290,"type":23},"2027-03-23",{"name":292,"class":50},"The Neurology Center of Southern California",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":249,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":301,"targetDuration":302,"studyType":224,"phases":4,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":163},"100602025","memory-deterioration-in-alzheimer-disease-100602025","NCT07118137","Memory Deterioration in Alzheimer Disease","Translational Neuroscience CAG for Alzheimer's Disease","MemAD","Inclusion Criteria:\n\n* Confirmed diagnosis based on current ICD criteria for AD or MCI .\n* \\>55years.\n* Norwegian native speaker\n* Lives at home and not in a health institution\n\nExclusion Criteria:\n\n* Patients with severe cognitive impairment that prevents assessment with the selected modalities (planned cut-off: CDR \\> 2).\n* Presence of brain tumors.\n* History of traumatic brain injury.\n* History of cranial surgery.\n* Contraindications to the selected imaging modalities (e.g., 7T MRI or EEG).\n* Diagnosis of other neurodegenerative diseases such as Parkinson's disease or ALS.\n\n  7T MRI contraindications:\n* Large tattoos close to the head region, permanent makeup or unremoveable piercings\n* Certain models of pacemakers (if pacemaker implantet, MRI physicist at 7T-lab will be conferred)\n* Implantet metal in body (clips, stents, prothesis, skrews, plates, teeth etc.)",{"count":201,"type":23},"1 Year","Semantic AD",[29,305,306,307],"Neurodegenerative Diseases","Magnetic Resonance Imaging","Memory Impairment","2026-08-12",{"date":285,"type":43},{"date":311,"type":43},"2023-10-15",{"date":313,"type":23},"2027-12-31",{"name":315,"class":50},"Norwegian University of Science and Technology",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":171,"enrollmentInfo":323,"targetDuration":4,"studyType":24,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100578260","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-bms-986368-for-the-treatment-of-agitation-in-participants-with-alzheimers-disease-100578260","NCT06808984","Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease","A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH\u002FMAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)","Inclusion Criteria\n\n* Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.\n* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.\n* History of agitation with onset at least four weeks prior to Screening.\n* MMSE-1 score ≤24.\n* NPI-NH agitation\u002Faggression sub-score ≥ 4.\n* Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).\n* Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.\n\nExclusion Criteria\n\n* Clinically significant delusions\u002Fhallucinations requiring hospitalization.\n* History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* History of major depressive episode with psychotic features during the 12 months prior to Screening.\n* History of delirium within 30 days of Screening.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":324,"type":23},120,[84],"This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH\u002FMAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.",[178,29],{"date":285,"type":43},{"date":330,"type":43},"2025-06-09",{"date":332,"type":23},"2028-01-07",{"name":334,"class":100},"Celgene",75,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":249,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":24,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":163},"100484769","dementia-care-partner-hospital-assessment-tool-100484769","NCT05592366","Dementia Care Partner Hospital Assessment Tool","Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care","Inclusion Criteria:\n\n* Provide unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of ADRD\n* 18 years or older\n\nExclusion Criteria:\n\n* Non-English speaking",{"count":344,"type":23},128,[62],"The purpose of this study is to see whether an adapted questionnaire called the Care Partner Hospital Assessment Tool (CHAT) for care partners of hospitalized patients living with Alzheimer's disease and related dementias (ADRD) (CHAT-AD) can help people with dementia receive better care after they go home from the hospital. Participants will be a care partner ('family member or friend') who provides unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of dementia. Participants can expect to be in this study for 14 days.",[29,280],{"date":258,"type":43},{"date":350,"type":43},"2024-04-02",{"date":352,"type":23},"2027-05",{"name":354,"class":50},"University of Wisconsin, Madison",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":24,"phases":363,"briefSummary":364,"conditions":365,"keywords":375,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":163},"100545064","using-the-ehr-to-advance-genomic-medicine-across-a-diverse-health-system-100545064","NCT06377033","Using the EHR to Advance Genomic Medicine Across a Diverse Health System","Using Behavioral Economics and Implementation Science to Advance the Use of Genomic Medicine Utilizing an EHR Infrastructure Across a Diverse Health System","Inclusion Criteria:\n\n* 18 years of age or older\n* diagnosed with one of the study conditions\n\nExclusion Criteria:\n\n* Under 18 years of age\n* not diagnosed with one of the study conditions",{"count":274,"type":23},[62],"Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.\n\nInnovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and\u002For patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.",[366,367,368,369,370,371,372,29,373,374],"Genetic Predisposition","Paraganglioma","Pheochromocytoma","ALS","Parkinson Disease","Polyneuropathies","Frontotemporal Dementia","Cardiomyopathy Non-ischemic","Thoracic Aortic Aneurysm",[376,377,378],"Genetic testing","Genomic medicine","Electronic health record","2026-08-11",{"date":258,"type":43},{"date":382,"type":43},"2024-06-10",{"date":384,"type":23},"2027-06-30",{"name":386,"class":50},"University of Pennsylvania",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":171,"enrollmentInfo":394,"targetDuration":4,"studyType":24,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":406},"100593845","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-adagio-1-100593845","NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","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","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: i) 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: A. 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. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\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  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) 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. iii) 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: i) 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\nC. 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":395,"type":23},426,[175],"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.",[29],"2026-08-10",{"date":379,"type":43},{"date":402,"type":43},"2025-07-10",{"date":404,"type":23},"2028-12-08",{"name":189,"class":100},159,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":24,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":431,"locationsCount":163},"100529458","early-age-related-hearing-loss-investigation-earhli-100529458","NCT06174038","Early Age-Related Hearing Loss Investigation (EARHLI)","Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias","EARHLI","Inclusion Criteria:\n\n* Age 55-75 years of age\n* Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)\n* Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear\n* Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \\>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years\n* Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)\n* Community-dwelling\n* Fluent in English or Spanish\n* Availability of participant in area for study duration\n\nExclusion Criteria:\n\n* Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\\\u003C45 years old)\n* Prior dementia diagnosis\n* Reported disability in ≥ 2 activities of daily living (ADLs)\n* Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)\n* Unwillingness to wear hearing aids regularly (≥8 hours\u002Fday)\n* Medical contraindications to the use of hearing aids (e.g., actively draining ear)\n* Corrected vision impairment (worse than 20\u002F63 on MNRead Acuity Chart in worse eye)\n* Untreatable conductive hearing loss with air-bone gap \\> 15 dB in two or more contiguous octave frequencies in both ears","75 Years",{"count":417,"type":23},150,[62],"Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD\u002FADRD).",[29,421,153],"Hearing Loss",[421,423,117,424,425,281,426,277],"Alzheimer's","Hearing Aid","Memory Loss","Audiogram",{"date":308,"type":43},{"date":429,"type":43},"2024-08-01",{"date":313,"type":23},{"name":432,"class":50},"Columbia University",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":249,"sex":18,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":24,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":163},"100347867","phase-1-uab-alzheimers-disease-center-core-cohort---tau-imaging-substudy-100347867","NCT03809351","UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy","AV1451 ADC","Inclusion Criteria:\n\n1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.\n2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.\n3. Negative urine or serum hCG test within 2 days of \\[F-18\\]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.\n\nExclusion Criteria:\n\n1. Meets any exclusion criteria for the UAB-ADC study.\n2. Inability or contraindication for undergoing MRI and\u002For PET imaging\n3. Inability to participate in the imaging studies due to severity of dementia","50 Years",{"count":442,"type":23},160,[26],"The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET\u002FMRI study will also be enrolled in an ongoing \\[C-11\\]PiB-PET\u002FMRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.",[29],{"date":308,"type":43},{"date":448,"type":43},"2020-07-08",{"date":450,"type":23},"2028-07",{"name":452,"class":50},"University of Alabama at Birmingham",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":249,"sex":18,"minAge":440,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":24,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":163},"100324386","phase-2-uab-alzheimers-disease-center-core-cohort---imaging-substudy-100324386","NCT03503331","UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy","PiB ADC","Inclusion Criteria:\n\n\\- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).\n\n2\\. Negative urine or serum B-hCG test within 2 days of \\[C-11\\]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.\n\nExclusion Criteria:\n\n1. Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).\n2. Inability or contraindication for undergoing MRI and\u002For PET imaging\n3. Inability to participate in the imaging studies due to severity of dementia",{"count":442,"type":23},[84],"The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \\[C-11\\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \\[C-11\\]PiB-PET, and cognitive status will be the primary outcome of this imaging study.",[29],{"date":308,"type":43},{"date":466,"type":43},"2018-04-20",{"date":468,"type":23},"2028-10",{"name":452,"class":50},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":477,"maxAge":415,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":489,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":4},"100651168","multisensory-40-hz-stimulation-for-alzheimers-disease-100651168","NCT07758751","Multisensory 40-Hz Stimulation for Alzheimer's Disease","A Randomized, Sham-Controlled Study of the Safety and Efficacy of Multisensory 40-Hz Stimulation in Patients With Alzheimer's Disease","Inclusion Criteria:\n\n1. Provision of written informed consent by the participant or the participant's legally authorized representative.\n2. Age 45 to 75 years, inclusive.\n3. Completion of at least primary school education.\n4. Diagnosis within the Alzheimer's disease spectrum according to the National 5.Institute on Aging and Alzheimer's Association criteria.\n\nMild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, defined by a Montreal Cognitive Assessment score of ≤24 for participants with middle school education or above, or ≤23 for participants with primary school education, and a Clinical Dementia Rating global score of 0.5 or 1.\n\n6.Evidence of Alzheimer's disease pathology based on a positive positron emission tomography, cerebrospinal fluid, or blood biomarker result.\n\n7.Alzheimer's disease-related medications are expected to remain stable during the study period.\n\nExclusion Criteria:\n\n1. Current or previous history of a neurological disorder other than Alzheimer's disease that may affect cognition or study assessments, including epilepsy, stroke, multiple sclerosis, poorly controlled migraine, intracranial injury, previous neurosurgery, or head trauma with residual neurological impairment.\n2. Contraindication to magnetic resonance imaging, electroencephalography, auditory stimulation, visual stimulation, or noninvasive brain stimulation.\n3. Current major depressive disorder or another psychiatric disorder that, in the investigator's judgment, may interfere with study participation or outcome assessment.\n4. Clinically significant structural abnormalities on brain magnetic resonance imaging, including hydrocephalus, stroke, or another structural lesion that may confound study results.\n5. Severe cardiovascular or pulmonary disease.\n6. Cognitive impairment primarily attributable to another disorder, including frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease dementia, or vascular dementia.\n7. Clinically significant suicide risk or a suicide attempt within the previous 12 months.\n8. Behavioral disturbance, including severe aggression, agitation, or impulsivity, that may interfere with adherence to study procedures.\n9. Current or planned treatment with an anti-amyloid monoclonal antibody during the study period.\n10. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","45 Years",{"count":479,"type":23},60,[62],"This study aims to evaluate the safety and preliminary efficacy of combined auditory and visual 40-Hz stimulation in participants with biomarker-confirmed Alzheimer's disease spectrum disorders. A total of 60 participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia will be randomly assigned in a 1:1 ratio to receive either active multisensory 40-Hz stimulation or sham stimulation. The intervention will be administered for 60 minutes once daily for 4 consecutive weeks. Clinical assessments, electroencephalography, multimodal magnetic resonance imaging, and blood biomarkers will be evaluated before and after the intervention. Additional clinical, electroencephalographic, and blood biomarker assessments will be performed at 3 and 6 months after the intervention.",[29],[484,485,486,487,488],"Alzheimer's disease","Mild cognitive impairment","Gamma entrainment","40-Hz stimulation","Multisensory stimulation","NOT_YET_RECRUITING","2026-08-06",{"date":379,"type":43},{"date":493,"type":23},"2026-09",{"date":495,"type":23},"2027-10-30",{"name":497,"class":50},"Beijing Tiantan Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":440,"maxAge":110,"enrollmentInfo":505,"targetDuration":4,"studyType":24,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":518},"100641850","phase-1-a-study-of-ly3439539-in-participants-with-alzheimers-disease-100641850","NCT07598370","A Study of LY3439539 in Participants With Alzheimer's Disease","A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease","Inclusion Criteria:\n\n* Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease\n* Have a Mini Mental Score Examination score of 16 to 24, inclusive\n* Meet plasma pTau criteria, as defined by the sponsor\n* Have body mass index within the range of 17 and 32 kilograms per square meter (kg\u002Fm²) (inclusive) at screening\n* Are women not of childbearing potential and men willing to practice effective contraception throughout the study.\n* Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.\n* Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).\n\nExclusion Criteria:\n\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants\u002Fcardiac pacemaker.\n* Have a screening MRI that shows evidence of significant abnormality.\n* Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.\n* Have a history of\n\n  * Severe or ongoing allergy or hypersensitivity reactions\n  * Hypersensitivity to immunizations or immunoglobulins\n  * Two or more clinically significant or severe drug allergies,\n  * Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions\n* Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions\n* Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.\n* Have criteria that would preclude a lumbar puncture (LP).\n* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.",{"count":201,"type":23},[26],"The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.\n\nParticipation in the study will last approximately 9 months with visits about once a month.",[29],[153,305,280],{"date":511,"type":43},"2026-08-07",{"date":513,"type":43},"2026-05-21",{"date":515,"type":23},"2027-08",{"name":517,"class":100},"Eli Lilly and Company",8,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":249,"sex":18,"minAge":199,"maxAge":527,"enrollmentInfo":528,"targetDuration":4,"studyType":24,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":72},"100651299","lived-experience-narratives-in-dementia-100651299","NCT07757178","Lived Experience Narratives in Dementia","Improving the Quality of Life for People Living With Dementia and Carers: The Design and Development of a Dementia Specific Online Narrative-Based Intervention With a Feasibility Study","LEND","General Inclusion Criteria (apply across WP1-WP3)\n\n* Adults aged 18+.\n* Able to give informed consent and participate meaningfully in the required tasks.\n* Adequate communication ability in the required study language\n\nGeneral Exclusion Criteria (apply across WP1-3)\n\n* Living in a hospital or healthcare institution at the time of the study.\n* Refusal or inability to provide informed consent, or lack of capacity to consent.\n* Inability to comprehend participant information or communicate meaningfully","99 Years",{"count":479,"type":23},[62],"The Lived Experience Narratives in Dementia (LEND) research programme involves five work packages (WP). WP1 explores how people living with dementia use narratives and how narratives can impact them. Findings will support the development of LEND theory. WP 2-3 focus on developing the digital Online LEND Intervention, assessing its usability and acceptability, and conducting a feasibility study within NHS memory assessment and community services. Activities across the first three WPs include interviews, focus groups, user-testing sessions, engagement evaluation interviews, and a two-arm randomised feasibility trial using a range of outcome measures. Findings from this stage will inform refinement of the intervention and determine the feasibility of progressing to a future randomised controlled trial (RCT) of the Online LEND Intervention. WP4 is the Online LEND Intervention two-arm RCT. WP5 involves dissemination. The protocol for WP4 and 5 have not yet been developed and rely on results from WP1-3.",[280,532,29,533,534],"Neuro-Degenerative Disease","Caregiver Burden","Caregiver Burnout","2026-08-05",{"date":379,"type":43},{"date":538,"type":43},"2025-11-17",{"date":540,"type":23},"2029-07",{"name":542,"class":50},"University of Nottingham",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":110,"enrollmentInfo":551,"targetDuration":4,"studyType":24,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":489,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":163},"100651059","restoring-vascular-and-insulin-function-to-augment-anti-amyloid-therapy-in-alzheimers-disease-100651059","NCT07756294","Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease","REstoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in ALZheimer'ss Disease (REVITAA-ALZ): A Placebo-controlled Trial of Intranasal Insulin vs. Empagliflozin in Mild Cognitive Impairment (MCI) or Early Alzheimer's Disease (AD) Treated With Anti-Amyloid Targeting Therapy (Lecanemab or Donanemab)","REVITAA-ALZ","Inclusion Criteria:\n\n* Fluent in English\n* Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment\n* Amyloid positive by PET or cerebrospinal fluid criteria\n* Stable medical condition for 3 months prior to screening visit\n* Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician)\n* Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit\n* If receiving an acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or memantine or both, must be stable on a dose for at least 30 days prior to Baseline Visit\n* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study clinician\n* Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities.\n\nExclusion Criteria:\n\n* A diagnosis of dementia other than Alzheimer's disease\n* History of a clinically significant stroke, history of transient ischemic attack within 12 months, or any history of seizures\n* Current evidence or history in past two years of head injury with loss of consciousness, any major psychiatric disorder including psychosis, unstable major depressive disorder, bipolar disorder\n* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus\n* Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit\n* Cancer within the past 2 years with the exception of non-melanoma skin cancers and non-metastatic prostate cancer that has been stable for at least 6 months\n* Pregnancy or possible pregnancy\n* Use of anticoagulants\n* Residence in a skilled nursing facility at screening\n* Use of an investigational agent within two months of screening visit\n* Regular use of alcohol, narcotics, anticonvulsants, anti-Parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case-by-case basis by study clinician)\n* Any history of immunologic disease (e.g. lupus, rheumatoid arthritis, Crohn's disease) or systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives\n* History of a bleeding disorder that is not under adequate control, including a platelet count less than 50,000 or INR greater than 1.5\n* Contraindications for MRI, including claustrophobia or the presence of contraindicated metal implants\u002Fcardiac pacemaker\n* Baseline MRI Findings: More than four microhemorrhages defined as 10mm or less at the greatest diameter; A single macro hemorrhage greater than 10mm at greatest diameter; An area of superficial siderosis; Evidence of vasogenic edema; More than two lacunar infarcts or stroke involving a major vascular territory; Severe subcortical hyperintensities consistent with Fazekas score of 3; Evidence of amyloid beta-related angiitis (ABRA); Cerebral amyloid angiopathy (CAA); Cerebral contusion, encephalomalacia, brain aneurysm or other vascular malformations, central nervous system infection, brain tumor, or other major intracranial pathology that may cause cognitive impairment",{"count":201,"type":23},[84],"The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.",[29],[556,557,558],"mild cognitive impairment","mild dementia","insulin",{"date":399,"type":43},{"date":561,"type":23},"2026-08",{"date":563,"type":23},"2028-04",{"name":565,"class":50},"Wake Forest University Health Sciences",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":20,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":580,"leadSponsor":582,"locationsCount":201},"100636859","phase-3-donanemab-ly3002813-trial-in-chinese-participants-with-cognitively-unimpaired-preclinical-alzheimers-disease-100636859","NCT07571161","Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease","A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease","Inclusion Criteria:\n\n* A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)\n* Clinical Dementia Rating-Global Score (CDR-GS) of 0\n* A plasma P-tau result consistent with amyloid pathology\n* A reliable study partner who:\n\n  * Provides written informed consent to participate in the study in their role\n  * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities\n  * Is of legal age (18 years of age or older) to consent\n  * Is available to conduct functional scales\n* Have adequate literacy, vision, and hearing for neuropsychological testing\n\nExclusion Criteria:\n\n* Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition\n* Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer\n* Have received active or passive immunization against amyloid beta (Aβ) in any other study\n* Have current or prior use of prescription medications for treatment of MCI or AD\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants\n* Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening",{"count":574,"type":23},140,[175],"The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last up to approximately 156 weeks, excluding screening.",[29],{"date":490,"type":43},{"date":236,"type":43},{"date":581,"type":23},"2030-04",{"name":517,"class":100},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":249,"sex":18,"minAge":80,"maxAge":171,"enrollmentInfo":589,"targetDuration":4,"studyType":224,"phases":4,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":601,"locationsCount":163},"100380860","autoimmune-features-of-neurodegenerative-disorders-100380860","NCT04239079","Autoimmune Features of Neurodegenerative Disorders","PD and age matched controls:\n\nFor PD participants (n=30):\n\nInclusion criteria:\n\n* Clinical diagnosed PD based on UK Brain Bank criteria for the clinical diagnosis of PD. And must demonstrate two of the following three, as modified from BioFIND criteria: rest tremor, rigidity, or bradykinesia, with dopaminergic medication benefit\n* Age at recruitment ≥ 55\n* Age at motor onset \\> 45\n* PD onset age between 50-75 years\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, history of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\\\u003C 5 years)\n* History of Dementia\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent.\n\nFor age-matched control participants (n=30):\n\nInclusion criteria:\n\n* Ages ≥55 years old\n* With lack of PD in first-degree blood relatives\n* Montreal Cognitive Assessment (MoCA): ≥26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent\n\nAD\u002FaMCI and age matched controls:\n\nFor AD\u002FaMCI participants (n=30):\n\nInclusion criteria:\n\n* Clinically diagnosed mild AD\u002Famnestic MCI. The severity will be accessed through the Clinical Dementia Rating Scale (CDR). CDR equal to 0.5 or 1 will be necessary to meet criteria. Participants with advanced AD stage will not be capable to give their consent.\n* Age ≥55 years old\n* Mini-Mental State Exam (MMSE): 20-26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Other forms of dementia including frontotemporal dementia or other dementia associated with parkinsonism such as Dementia with Lewy bodies (DLB), or Parkinson's disease Dementia (PDD), Progressive Supranuclear Palsy or corticobasal degeneration.\n* History of Parkinson's disease (PD)\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent\n\nFor age-matched control participants (n=30):\n\nInclusion criteria:\n\n* Healthy volunteers ≥55 years old\n* CDR: 0\n* MoCA: ≥26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* History of Parkinson's disease (PD)\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent",{"count":324,"type":23},"This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). The investigators plan to recruit 30 PD, 30 AD\u002FAmnestic Mild Cognitive Impairment (aMCI), and 60 age matched healthy controls in this study to study the role of immune response in PD and AD.\n\nThe study involves up to two study visits involving brief questionnaires and blood draw of up to 250cc (approximately 17 tablespoons) to be collected. More ways to participate, including 1) smaller amount blood donation (up to 100cc per visit for 1-2 visits); and 2) participation via tele-visit and mobile phlebotomy visits (blood donation up to 50cc, \\~5 tubes, by a certified mobile phlebotomist at home\u002Flocation of choice) now available.",[370,29,148],[593,594,484,148],"Autoimmune features","Parkinson's disease","2026-07-31",{"date":597,"type":43},"2026-08-04",{"date":599,"type":43},"2019-05-01",{"date":450,"type":23},{"name":432,"class":50},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":249,"sex":18,"minAge":477,"maxAge":110,"enrollmentInfo":609,"targetDuration":611,"studyType":224,"phases":4,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":72},"100604771","an-observational-study-on-lecanemab-treatment-for-early-alzheimers-disease-100604771","NCT07153848","An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease","A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment","Inclusion criteria (all of the following must be met simultaneously):\n\nMild Alzheimer's Disease (AD):\n\n1. Age ≥ 45 years but ≤ 85 years;\n2. Literacy level of elementary school and above (i.e., ≥3 years of education);\n3. Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);\n4. Clinical Dementia Rating Scale CDR-global = 1 point;\n5. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain.\n\nAD-derived mild cognitive impairment (aMCI) inclusion criteria (must meet all of the following conditions at the same time):\n\n1. Age: 45 years or older but ≤85 years;\n2. Literacy level elementary school and above (i.e., ≥3 years of education);\n3. Meeting Peterson's 2004 diagnostic criteria for MCI:\n\n   (i) Complaint of memory impairment that can be confirmed by an informed person; (ii) objective evidence of memory impairment (memory test scores 1-1.5 standard deviations below normal controls matched for age and literacy; e.g., Huashan Hospital's recommended cut-off values for those with elementary school literacy or above are as follows: long-delayed recall 50-59 years old ≤ 5, 60-69 years old ≤ 4, 70-79 years old ≤ 3, 80-89 years old ≤ 2, or re-recognition scores of 50-59 years old ≤ 20, 60-69 age ≤19 points, 70-79 years ≤18 points, 80-89 years ≤16 points); (iii) Overall cognitive functioning was largely preserved, with CDR-global = 0.5 points and MMSE: ≥24 points for those with junior high school or higher education used in this study;\n\n   ④ Daily life ability remains normal (basically able to complete going out by transportation and shopping and counting, etc.);\n\n   ⑤ Does not meet the International Classification of Diseases Diagnostic Manual, 10th edition dementia criteria (for research purposes) and the National Institute of Neurological and Speech-Language Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) likely diagnostic criteria for AD dementia; (vi) Aβ-PET scan suggested extensive deposition of Aβ plaques in the brain.\n\nNormal control Inclusion criteria (all of the following must be met simultaneously).\n\n1. Age ≥55 years but ≤85 years;\n2. Elementary school 3 years of education and above;\n3. MMSE: ≥26 points for those with junior high school or higher education;\n4. CDR=0;\n5. Activity of Daily Living Scale (ADL) score ≤ 20;\n6. No significant deposition of Abeta in the brain as indicated by Aβ-PET scan.\n\nExclusion Criteria (excluded if any of the following conditions were met):\n\n1. Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;\n2. Presence of other neurological disorders that may cause brain dysfunction (e.g., schizophrenia, severe anxiety and depression, frontotemporal lobe dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, and normal cranial pressure hydrocephalus, etc.);\n3. Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;\n4. Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;\n5. Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);\n6. Presence of contraindications to NMR such as metal implantation in the body;\n7. Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;\n8. Refusal to sign the informed consent.",{"count":610,"type":23},400,"18 Months","The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.",[29],[615,29,616,617],"lecanemab","biomarkers","blood","2026-07-30",{"date":595,"type":43},{"date":621,"type":43},"2024-07-01",{"date":313,"type":23},{"name":624,"class":50},"First Affiliated Hospital of Zhejiang University"]