[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100622414","autophagy-enhancers-to-reduce-sleep-disturbances-100622414",false,"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,"ALL","55 Years","70 Years",{"count":22,"type":23},76,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30],"Mild Cognitive Impairment Due to Alzheimer's Disease","Subjective Cognitive Decline (SCD)",[32,33,34,35,36,37,38,39,40],"Mild Cognitive Impairment","Autophagy","sleep","Spermidine","memory consolidation","electroencephalography","polysomnography","randomized controlled trial","subjective cognitive decline","RECRUITING","2026-06-29",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":45},"2025-10-28",{"date":49,"type":23},"2029-05",{"name":51,"class":52},"University Medicine Greifswald","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":18,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":53},"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":64,"type":23},16,[66],"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.",[69,70,29],"Dementia","Alzheimers Disease",[72,69,32],"Alzheimers","2026-02-10",{"date":75,"type":45},"2026-02-12",{"date":77,"type":45},"2025-09-16",{"date":79,"type":23},"2026-12",{"name":81,"class":52},"Brigham and Women's Hospital"]