[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-cognitive-impairment-due-to-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-cognitive-impairment-due-to-alzheimers-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100648491","phase-3-an-evaluation-of-treatments-for-sustained-clinical-response-18-months-in-symptomatic-alzheimers-disease-100648491",false,"NCT07724132","An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease","Alzheimer's Disease- Systematic Multi-Arm Adaptive Randomised Trial","AD-SMART","Inclusion Criteria\n\n* Patient meets all inclusion criteria:\n\n  1\\. Adults aged ≥55 years on the day of screening, no upper age limit 2. Either:\n  1. Confirmed clinical diagnosis of Alzheimer's Disease (AD)\n  2. Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vascular Dementia 3. Mini Mental State Examination score of ≥17 4. Confirmatory blood biomarker testing (pTau-217) (positive or intermediate via validated assays) ≤ 365 days prior to screening or between screening and randomisation or a positive amyloid PET scan (if available) or a positive amyloid CSF test (if available) 5. Randomisation should ideally take place within 4 weeks of the screening visit but no later than 8 weeks after the screening visit 6. Must be able and willing to comply with the treatment and assessment schedule and requirements including being able to start trial treatment ≤ 2 weeks after randomisation 7. Willing and able to have MRI scans in accordance with the assessment schedule unless participant is clinically contraindicated due to:\n\n  \u003C!-- -->\n\n  1. Pacemakers or defibrillators (unless MRI-conditional models)\n  2. Aneurysm clips, stents or metal implants (unless MRI safe)\n  3. Cochlear implants (unless MRI-conditional models)\n  4. Metal fragments in the body\n  5. Severe claustrophobia 8. Negative pregnancy test ≤4 weeks prior to randomisation for women of child-bearing potential 9. Normal liver function at screening consisting of all the following:\n\n  \u003C!-- -->\n\n  1. Total serum bilirubin \\\u003C1.5 x ULN (except for participants with Gilbert's disease, for whom the upper limit of total serum bilirubin is 51.3 μmol\u002Fl or 3mg\u002Fdl)\n  2. Alanine aminotransferase (ALT) \\\u003C3 x ULN;\n  3. Alkaline phosphatase \\\u003C3 x ULN 10. Documented participant and study partner informed consent 11. If a participant is being re-randomised into the trial, additional timing of entry requirements must also be met:\n\n  \u003C!-- -->\n\n  1. For participants being re-randomised after completing 18 months' follow-up and the arm was not closed due to lack of activity, a 12-week washout period from last dose of IMP must be completed before their screening visit. If the efficacy analysis indicates that the IMP was ineffective then this washout period can be reduced to 6 weeks.\n  2. For participants being re-randomised following treatment arm termination due to lack of activity, a 6-week washout period from their last dose of IMP must be completed prior to screening assessment\n\n     Study Partner inclusion criteria:\n     1. Participant that meets the AD-SMART eligibility criteria has consented to participation in the trial\n     2. Has at least twice-weekly contact with participant\n     3. Be 18 years or older at the time of providing consent\n     4. Willing to complete study partner questionnaires as outlined in visit schedule\n     5. Willing to attend remote and in-person study visits with participant\n     6. Documented informed consent\n\n     Exclusion Criteria:\n* Patient meets none of the exclusion criteria:\n\n  1. Fazekas Score =3 reported from an MRI taken at any time prior to randomisation, if an MRI is not clinically contraindicated (reasons specified in Inclusion Criteria 7) A. MRI does not need to be repeated if Fazekas score = 0, 1 or 2 reported from an MRI performed ≤365 days to screening visit (if Fazekas score has not been reported, refer to Section 7.4) b. MRI should be conducted if participant is not clinically contraindicated to MRIs and previous MRI where Fazekas score = 0, 1 or 2 was \\>365 days or previous MRI scan is not available for Fazekas score reporting or participant has never had an MRI\n  2. Clinical diagnosis of Dementia with Lewy bodies\n  3. Clinical diagnosis of Parkinson's disease\n  4. Clinical diagnosis of Frontotemporal Dementia\n  5. Cardiac failure (American Heart Association Stage C or D)\n  6. Significant respiratory comorbidity (hospitalisation within the previous ≤6 months due to respiratory comorbidity)\n  7. Renal failure (CKD IV or eGFR ≤45 mL\u002Fmin\u002F1.73m²) at any time point prior to randomisation\n  8. Malignancy (except if in complete remission) e.g. solid organ or haematological or melanoma\n  9. Score of ≥1 on C-SSRS at screening visit\n  10. Individuals without an identified study partner (refer to Section 4 for further details on study partners)\n  11. Individuals who have an Alzheimer's Disease or Central Nervous System medication (e.g. antidepressant) change or dose change ≤28 days prior to screening\n  12. Use of an Investigational Medicinal Product (IMP) or Investigational Medical Device (IMD) ≤26 weeks prior to randomisation (except for AD-SMART participants that are being re-randomised. See Section 5.4 for further information).\n  13. Receiving antibody-based amyloid clearing treatment for Alzheimer's Disease within 26 weeks prior to randomisation\n  14. Unable or unwilling to comply with study procedures\n  15. Unable to swallow whole capsules\n  16. Individuals who are living in the same household as an AD-SMART participant who is actively taking trial medication\n  17. Female participants that are pregnant or breastfeeding\n  18. Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception (see acceptable methods of contraception) whilst on trial treatment and up to 12 weeks after the last dose of study drug\n  19. Male participants with a partner of child-bearing potential unwilling or unable to use an acceptable method of contraception whilst on trial treatment and up to 12 weeks after the last dose of the study drug.\n  20. Male participants unwilling to desist from sperm donation during the trial and for 12 weeks after the last dose of trial treatment\n  21. Current or previous exposure to any of the currently recruiting AD-SMART IMPs ≤26 weeks before randomisation.\n  22. History of alcohol and\u002For drug abuse and\u002For dependence within the 5 years prior to screening visit.\n  23. Any concurrent medical condition, abnormal laboratory tests or uncontrolled, clinically significant systemic disease that, in the opinion of the Investigator, could cause study participation to be detrimental to the participant.\n  24. Participants who are not eligible for any of the trial IMPs, according to the eligibility criteria listed in the individual drug appendices. Please note that participants can enter the trial if they are eligible for at least one of the trial treatment arms, but do not need to be eligible for all.\n\nArm-specific eligibility criteria:\n\nAtomoxetine-specific exclusion eligibility criteria:\n\nIn addition to the core inclusion and exclusion criteria, refer to section 2.2 of AD-SMART Appendix 1 Atomoxetine' for the arm-specific exclusion eligibility criteria for the Atomoxetine arm which must also be met.\n\nMetformin-specific exclusion eligibility criteria:\n\nIn addition to the core inclusion and exclusion criteria, refer to section 2.2 of AD-SMART Appendix 2 Metformin' for the arm-specific exclusion eligibility criteria for the metformin arm which must also be met.","ALL","55 Years",{"count":20,"type":21},1200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.",[27,28,29],"Alzheimer's Disease (AD)","Mild Cognitive Impairment Due to Alzheimer's Disease","Alzheimer Disease Dementia","RECRUITING","2026-07-21",{"date":33,"type":34},"2026-07-23","ACTUAL",{"date":36,"type":21},"2026-07-24",{"date":38,"type":21},"2031-03",{"name":40,"class":41},"University College, London","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100622414","autophagy-enhancers-to-reduce-sleep-disturbances-100622414","NCT07383311","Autophagy-Enhancers to Reduce Sleep Disturbances","Autophagy-Enhancers to Reduce Sleep Disturbances: A Combined Approach","SpSleep","Inclusion Criteria (SCD participants):\n\n* Men and women\n* Written consent to participate in the study\n* German at native speaker level\n* Age between 55 and 70 years\n* Subjective Cognitive Decline operationalized as:\n\n  1. Subjectively reported decline in cognitive function (particularly memory) despite objectively normal cognitive performance (e.g., WMS-LM)\n  2. Preservation of functional independence\n  3. No dementia\n\nInclusion Criteria (MCI patients):\n\n* Men and women\n* Written consent to participate in the study\n* German at native speaker level\n* Age between 55 and 70 years\n* Mild cognitive impairment (MCI) operationalized as:\n\n  1. A change in cognitive abilities reported by the patient, relatives or clinic staff (i.e. historical or observed evidence of deterioration over time)\n  2. Objective evidence of memory impairment (at least 1.0 Standard Deviation (SD) below the normal range on the Wechsler Logical Memory Scale (WMS-LM)); other cognitive domains may also be affected (i.e. amnestic MCI and amnestic + MCI)\n  3. Preservation of independence of functional abilities\n  4. No dementia\n\nExclusion Criteria (SCD and MCI participants):\n\n* Patients who are unable to give informed consent\n* Polyamine intake via dietary supplements and\u002For participation in corresponding intervention studies\n* Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)\n* Any condition that impairs clinical or neuropsychological examination procedures\n* Diabetes mellitus\n* Polycystic ovary syndrome\n* Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion\n* Previous stroke\n* Severe untreated medical problems or unstable medical condition\n* Current major depressive episode\n* Psychotic disorder\n* Bipolar disorder\n* Current or previous substance abuse\n* Other neurodegenerative disease, e.g. Parkinson's disease\n* Vascular dementia\n* Alcohol abuse\n* Participation in an interventional study in the last 3 months and during the entire study period\n* Sleep disorders\n* Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication)\n* Known intolerances or allergies to wheat germ, gluten or histamine\n\nInclusion criteria (healthy controls):\n\n* Men and women\n* Written consent to participate in the study\n* German at native speaker level\n* Age between 55 and 70 years\n* Subjective cognitive disorders are denied\n\nExclusion criteria (healthy controls):\n\n* Subjects who are not able to give informed consent\n* Polyamine intake via dietary supplements and\u002For participation in corresponding intervention studies\n* Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)\n* Mild cognitive impairment (MCI), defined as described above in the patient inclusion criteria\n* Any condition that interferes with clinical or neuropsychological examination procedures\n* Diabetes mellitus\n* Polycystic ovary syndrome\n* Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion\n* Previous stroke\n* Severe untreated medical problems or unstable medical condition\n* Current major depressive episode\n* Psychotic disorder\n* Bipolar disorder\n* Current or past substance abuse\n* Other neurodegenerative disease, e.g. Parkinson's disease\n* Vascular dementia\n* Alcohol abuse\n* Participation in an interventional study in the last 3 months and during the entire study period\n* Sleep disorders\n* Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication)",true,"70 Years",{"count":54,"type":21},76,[56],"NA","This clinical trial investigates the effects of spermidine supplementation on sleep quality and sleep-dependent memory consolidation in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI), two populations at increased risk of future cognitive decline and dementia. Impaired sleep has been identified as a modifiable factor contributing to cognitive decline, and interventions targeting sleep architecture could offer therapeutic potential to prevent or slow down this decline.\n\nSpermidine is a naturally occurring polyamine found in foods such as wheat germ and soybeans. It induces autophagy, a cellular degradation and recycling process essential for neuronal maintenance and function. In animal studies, spermidine has been shown to improve memory performance, reduce neuroinflammation, and support mitochondrial health. Preliminary findings from human trials in individuals with SCD or MCI suggest potential cognitive benefits of spermidine, but results are not unequivocal, and the impact on sleep has not been systematically evaluated.\n\nIn this randomized, double-blind, placebo-controlled trial, 76 participants aged 55 to 70 years with SCD or MCI will receive either spermidine (6 mg\u002Fday) or a placebo for 12 weeks. Sleep will be evaluated using overnight EEG in a controlled laboratory setting, focusing on measures such as slow-wave sleep and sleep spindle activity. Memory performance will be assessed before and after the intervention using standardized neuropsychological testing. Numerical skills will be tested at baseline only to compare SCD and MCI participants with healthy controls.\n\nBlood samples will be collected to quantify metabolic indicators, neurodegeneration-related biomarkers, and autophagy-associated proteins. A control group of 38 cognitively healthy individuals will undergo comparable sleep and cognitive assessments without receiving any supplementation.\n\nThe primary objective of the study is to characterize the impact of spermidine on sleep-dependent memory consolidation and to identify associated biological changes relevant to aging and neurodegeneration. The results may inform the development of non-pharmacological strategies aimed at preserving cognitive function in individuals at risk for dementia.",[28,59],"Subjective Cognitive Decline (SCD)",[61,62,63,64,65,66,67,68,69],"Mild Cognitive Impairment","Autophagy","sleep","Spermidine","memory consolidation","electroencephalography","polysomnography","randomized controlled trial","subjective cognitive decline","2026-06-29",{"date":72,"type":34},"2026-07-02",{"date":74,"type":34},"2025-10-28",{"date":76,"type":21},"2029-05",{"name":78,"class":41},"University Medicine Greifswald",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":79},"100553704","phase-2-assessment-of-foralumab-safety-and-modulation-of-microglial-activation-in-alzheimers-disease-100553704","NCT06489548","Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease","Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease","Inclusion Criteria:\n\n1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines for Early Symptomatic Alzheimer's Disease (AD) with a 20-30 MMSE score, Clinical Dementia Rating (CDR) global score of 0.5 or 1, and impaired memory performance below an education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall (LM-IIa) of the Wechsler Memory Scale- Revised (WMS-R) (127) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2).\n2. Age between 60 and 85 years (inclusive).\n3. Good general health with no disease likely to interfere with the study assessments.\n4. On a stable medication regimen for eight weeks prior to the study and is anticipated to remain stable during the study.\n5. Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). If a woman is of childbearing potential, her partner must use barrier contraception throughout the study.\n6. Amyloid-positive PET scan (performed only if the subject meets all other inclusion criteria). An amyloid-positive PET scan is classified by an SUVR composite score cutoff of 1.18 units. Prior evidence of amyloid positivity by PET or CSF will also be accepted for eligibility.\n7. Ability to understand and provide informed consent.\n8. Has availability of a study partner who has regular contact with the participant and knows him\u002Fher well.\n\nExclusion Criteria:\n\n1. Any significant neurologic disease including Parkinson's disease, stroke, multiinfarct dementia, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent neurologic deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.\n2. Clinically significant or unstable medical conditions, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases.\n3. History of autoimmune disease.\n4. Current treatment with immunomodulatory or immunosuppressive drugs or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month.\n5. Major depressive disorder (within the past 1 year), or a history of bipolar disorder, or a history of schizophrenia.\n6. History of alcohol or substance abuse or dependence within the past two years.\n7. History of malignancy within the past 3 years.\n8. Clinically significant abnormalities in screening laboratories (defined as greater than mild on the FDA's vaccine toxicity grading scale).\n9. Participation in another clinical trial of an investigational drug concurrently or within the past 30 days.\n10. Low affinity TSPO binders (for PET ligand \\[18F\\]PBR06) determined by having a Thr\u002FThr polymorphism in the TSPO gene at screening.\n11. Sensitivity to florbetapir F18.\n12. Active COVID-19 disease.\n13. Amyloid-negative PET scan.\n14. COVID-19 vaccine within the past ten days or any other vaccine within the past seven days (at dosing)","60 Years","85 Years",{"count":90,"type":21},16,[92],"PHASE2","This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.\n\nThe trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.",[95,96,28],"Dementia","Alzheimers Disease",[98,95,61],"Alzheimers","2026-02-10",{"date":101,"type":34},"2026-02-12",{"date":103,"type":34},"2025-09-16",{"date":105,"type":21},"2026-12",{"name":107,"class":41},"Brigham and Women's Hospital"]