[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimer-dementia-ad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimer-dementia-ad":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,79,105,130,175,203,236,265,312,340,371,396,440,470,496,525,552,576,599,624,645],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644884","clinical-risk-score-prediction-for-risk-of-dementia-among-late-life-population-with-depression-100644884",false,"NCT07676851","Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression","Development of a Clinical Risk Score Prediction Tool for 5-, 9-, and 13-year Risk of Dementia Among Late-life Population With Depression: a Longitudinal Cohort Study","Inclusion Criteria:\n\n* Adults aged ≥50 years.\n* A diagnosis of depression clearly recorded by a clinician in the electronic medical record at baseline (based on structured or unstructured diagnostic documentation formed through routine clinical practice).\n* Complete baseline electronic medical record data available, including at least demographic information (age, sex), clinical diagnoses, comorbidities, and medication records.\n* At least one follow-up record available in the electronic medical record system to enable determination of incident dementia outcomes.\n* Informed consent provided for the use of routine medical data for this research analysis.\n\nExclusion Criteria:\n\n* Any type of dementia diagnosis recorded in the electronic medical record at baseline (including Alzheimer's disease, vascular dementia, and other types of dementia).\n* Medical record documentation indicating that the diagnosis of dementia preceded the diagnosis of depression, or an inability to clearly determine the chronological order of the two diagnoses.\n* Presence of other neurological diseases at baseline that may independently cause severe cognitive impairment (e.g., Parkinson's disease, multiple sclerosis, brain tumor, normal pressure hydrocephalus).\n* Missing key baseline electronic medical record data that would preclude subsequent risk model analysis.\n* Incomplete follow-up information or inability to clearly confirm incident dementia outcomes through the electronic medical record system.\n* Refusal to participate in the study or withdrawal of informed consent.",true,"ALL","50 Years",{"count":20,"type":21},44,"ESTIMATED","13 Years","OBSERVATIONAL","The goal of this observational study is to learn about the ability of a point risk score prediction model, developed using electronic medical record data, to predict the risk of progression from geriatric depression to dementia in older Chinese adults. The main questions it aims to answer are:\n\nDoes a higher point risk score increase the risk of developing dementia in older adults with depression?\n\nWhat is the accuracy of the point risk score prediction model in identifying individuals at high risk of dementia among older adults with depression?\n\nParticipants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. The research team will collect data from their electronic medical records, including depression diagnoses, dementia diagnoses, comorbidities, medication records, and follow-up information. The point risk score will be calculated based on these routinely collected clinical data.",[26,27,28,29,30,31,32,33,34],"Alzheimer Dementia (AD)","Dementia","Late Life Depression (LLD)","Risk Scores","Prediction","Chinese Population","Obs e r","Observational Cohort Study","External Validation","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2006-06-01",{"date":43,"type":21},"2030-06-30",{"name":45,"class":46},"Second Affiliated Hospital of Nanchang University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100642024","phase-1-interleukine-2-il-2-plus-semaglutide-in-alzheimers-disease-100642024","NCT07651319","Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease","A Phase Ib Clinical Trial, Using Interleukin-2 (IL-2) and Semaglutide in Patients With Alzheimer's Disease","Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.\n* Male or female age 50 to 86 years\n* MMSE between 16-26\n* Albumin greater than or equal to 3.0mg\u002FdL\n* White Blood Count (WBC) \\>3,500\u002Fmm3; platelets \\>100,000\u002Fmm3; hematocrit (HCT) \\>32%.\n* INR\\\u003C1.4\n* If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study.\n* English language speaking\n* Formal education of eight or more years\n* Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening\n* A family member or caretaker who is expected to be consistently available, administer study drugs of IL-2 and attend study visits throughout the study.\n* For AD patients with limited decision-making capacity, the legally authorized representative (LAR) should be present and consent based on the patient's best interest.\n\nExclusion Criteria:\n\n* Any untreated bacterial, fungal or viral infection\n* Renal dysfunction indicated by serum creatinine greater than 1.5 mg\u002FdL\n* Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal\n* Clinically significant pulmonary dysfunction, including a history of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease \\[COPD\\]) associated with functional limitation, or FEV₁ \\\u003C 75% of predicted for age and height when pulmonary function testing indicated to evaluate ongoing respiratory symptoms\n* Clinically significant cardiac dysfunction, including a history of uncontrolled cardiac arrhythmias, prior cardiac tamponade, or unstable angina or myocardial infarction within 3 months prior to screening, or clinically significant abnormalities on baseline electrocardiogram (ECG). LVEF\\\u003C 40% in echocardiography if clinically indicated based on ongoing cardiac symptoms or abnormal ECG findings\n* Hypersensitivity or allergy to IL-2\n* History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening.\n* History of hemorrhage or infarct or \\> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.\n* Clinical or laboratory findings consistent with:\n\n  1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)\n  2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)\n  3. Seizure disorder\n  4. History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)\n  5. Clinically significant abnormal T4 or TSH\n* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:\n\n  1. Respiratory insufficiency\n  2. Bradycardia (\\\u003C45\u002Fmin.) or tachycardia (\\>100\u002Fmin.)\n  3. Poorly managed hypertension (systolic \\>160 mm Hg and\u002For diastolic \\>95 mm Hg) or hypotension (systolic \\\u003C90 mm Hg and\u002For diastolic \\\u003C60 mm Hg)\n  4. Uncontrolled diabetes defined by HbA1c \\>8%\n* History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.\n* History of acute\u002Fchronic hepatitis B or C and\u002For carriers of hepatitis B\n* History of organ allografts\n* Current treatment with insulin or insulin secretagogues (including sulfonylureas or meglitinides)\n* Prior GLP-1 RA administration or natural GLP1 supplements intake within the past 6 months\n* Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty, etc.).\n* Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg\u002Fday, quetiapine ≤100 mg\u002Fday, olanzapine ≤5 mg\u002Fday, and aripiprazole ≤10 mg\u002Fday), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests.\n* Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.\n* Use of concomitant CYP-metabolized medications with a narrow therapeutic index including warfarin, calcineurin inhibitors, or theophylline)\n* Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening\n* Suspected or known allergy to any components of the study treatments.\n* Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.\n* Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR \\>1.4 or other coagulopathy; platelet count of \\\u003C100,000\u002FμL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.\n* Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.","86 Years",{"count":57,"type":21},30,"INTERVENTIONAL",[60,61],"PHASE1","PHASE2","Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited. Growing evidence suggests that inflammation in the brain and the body plays a key role in the onset and progression of AD. In particular, immune cells called regulatory T cells (Tregs), which normally help control inflammation, are impaired in AD individuals. This leads to increased activity of harmful immune pathways that worsen brain injury. Interleukin-2 (IL-2) is a drug that can restore the function of Tregs. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, are a class of drugs currently used to treat diabetes and obesity. Beyond their metabolic effects, GLP-1RAs also reduce inflammation, protect brain cells, and improve cellular energy balance. Laboratory studies, including our own, show that combining IL-2 with semaglutide has stronger effects than either drug alone. Together, they enhance Treg function, dampen harmful inflammatory responses, and improve cell survival. These findings support testing IL-2 plus semaglutide as a novel combination therapy for AD. We now propose a clinical trial to evaluate the safety, feasibility, and biological effects of this strategy. The study will enroll 30 individuals with AD, ages 50 to 86, who have a confirmed diagnosis by amyloid PET brain imaging and a Mini-Mental State Exam score between 16 and 26. Participants will be randomly assigned to one of three groups: (1) placebo, (2) low-dose IL-2 alone, or (3) IL-2 combined with semaglutide. Throughout the trial, participants will undergo regular medical exams, blood tests, and safety monitoring. We will measure how the treatment affects Tregs and other immune cells, inflammatory markers in blood and CSF, and established Alzheimer's biomarkers such as amyloid beta, tau, and neurofilament light chain. Cognitive and functional assessments will also be conducted to explore potential benefits on memory and daily living skills. If successful, this study will provide the first evidence that a dual immunotherapeutic strategy can safely modify disease-related processes in AD. Such findings would lay the foundation for larger clinical trials and could open the door to a new, multimodal approach to slowing or preventing Alzheimer's progression.",[26],[65,66,67,68,69],"Alzheimer's Disease","inflammation","Immunotherapy","IL-2","Semaglutide","2026-06-10",{"date":72,"type":39},"2026-06-16",{"date":74,"type":21},"2026-07",{"date":76,"type":21},"2029-12",{"name":78,"class":46},"The Methodist Hospital Research Institute",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100640204","bci-with-40hz-stimulation-in-alzheimers-disease-100640204","NCT07618481","BCI With 40Hz Stimulation in Alzheimer's Disease","EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study","Inclusion Criteria:\n\n1. Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.\n2. Age between 50 and 80 years, inclusive.\n3. Positive Aβ-PET scan result.\n4. Has a stable caregiver who can assist with daily stimulation intervention.\n5. Chronic medical conditions stable for at least 30 days.\n6. Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).\n7. Good mobility (able to walk independently or with assistive devices).\n8. Willing and able to provide voluntary signed informed consent.\n\nExclusion Criteria:\n\n1. History of epilepsy or seizure disorder.\n2. Inability to undergo MRI or presence of significant abnormalities on MRI screening.\n3. Geriatric Depression Scale (GDS) score \\> 6.\n4. Current suicidal ideation or suicide attempt within the past 6 months.\n5. Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis\u002Fencephalitis) or multiple concussions; metabolic\u002Fsystemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).\n6. Psychiatric disorders.\n7. Severe cardiac disease, chronic liver\u002Fkidney\u002Frespiratory disease, or uncontrolled diabetes mellitus or thyroid disease.\n8. History of drug or alcohol abuse within the past 12 months.\n9. Current exposure to anti-Aβ antibody immunotherapies.\n10. Current use of memantine within 30 days prior to intervention.\n11. Life expectancy \\\u003C 24 months.","80 Years",{"count":88,"type":21},90,[90],"NA","This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.",[26],[65,94],"Non-Invasive Brain Stimulation","2026-06-02",{"date":97,"type":39},"2026-06-03",{"date":99,"type":39},"2026-05-01",{"date":101,"type":21},"2027-10-31",{"name":103,"class":46},"Ruijin Hospital",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":58,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100640973","phase-4-evaluating-the-efficacy-and-safety-of-lecanemab-in-alzheimers-disease-through-multi-omics-approachs-100640973","NCT07604896","Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","Inclusion Criteria:\n\n* Age: 50 to 90 years old.\n* No gender restrictions.\n* Patients with MCI and mild AD.\n* The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.\n* Positive Amyloid protein confirmed by amyloid-PET or CSF.\n* There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.\n* Agree to participate in the research and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment caused by reasons other than AD.\n* There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.\n* A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.\n* Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.\n* There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.\n* There are contraindications for MRI scans, including the installation of cardiac pacemakers\u002Fdefibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).\n* There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.\n* Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.\n* Surgical operations under general anesthesia are planned to be performed during the research period.\n* Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.","90 Years",{"count":114,"type":21},200,[116],"PHASE4","This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.\n\nThe primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT\u002FOCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.",[119,26,120],"Alzheimer s Disease","MCI-AD, Early Stage Alzheimer's Disease","2026-05-17",{"date":123,"type":39},"2026-05-22",{"date":125,"type":39},"2026-01-01",{"date":127,"type":21},"2028-12-31",{"name":129,"class":46},"First Affiliated Hospital of Wenzhou Medical University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":140,"conditions":141,"keywords":150,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":47},"100608375","speech-based-artificial-intelligence-for-detection-of-dementia-in-danish-patients-detectai-100608375","NCT07200739","Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients (DetectAI)","Development of Deep Learning Models for Detection of Neurodegenerative Diseases Using Speech - a Danish Language-based Artificial Intelligence Study (DetectAI)","DetectAI","Inclusion Criteria:\n\nModel A (patient participants)\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n* A diagnosis of either MCI or AD, given at the SUH memory clinic within 6 months before enrollment\n\nModel A (cognitively healthy controls)\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n\nModel B:\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n\nExclusion Criteria:\n\nModel A:\n\nPatients:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE score \\\u003C 16\n* Concomitant diagnoses which are expected to influence cognitive impairment (eg. depression)\n* Patients unable to give consent\n* Patients with alcohol consumption \\>21 standard alcohol units per week\n* Any history of speech or language impairment predating the current condition\n\nCognitively healthy controls:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE \\\u003C 26 and ACE \\\u003C 90\n* Clinical, laboratory, or neuroradiological findings that could affect cognitive functions\n* Known diseases which are expected to impair cognitive functions\n* Any history of speech or language impairment predating the current condition\n* Patients with alcohol consumption \\>21 standard alcohol units per week.\n\nModel B:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE score \\\u003C 16\n* Patients unable to give consent\n* Patients with concomitant psychosis or severe psychiatric comorbidities other than depression\n* Any history of speech or language impairment predating the current condition",{"count":139,"type":21},440,"The goal of this observational study is to learn if an artificial intelligence (AI)-based speech analysis tool can identify which patients with memory problems need specialist evaluation at a memory clinic. The main questions it aims to answer are:\n\nCan the AI model accurately distinguish between patients who need referral to a memory clinic (those with dementia or Mild Cognitive Impairment) and patients who don't (those with normal cognition or memory problems from other causes like depression)? Which speech patterns and cognitive test features are most useful for making this distinction?\n\nResearchers will compare speech recordings and cognitive test results from patients diagnosed with dementia or MCI to those from patients with normal cognition or non-neurodegenerative cognitive impairment to see if the AI model can reliably predict who needs specialist dementia care.\n\nParticipants will:\n\nComplete standard cognitive tests at the memory clinic Perform structured speech tasks while being audio-recorded Receive their usual clinical evaluation and diagnosis from memory clinic specialists\n\nThe results of this study will help develop a tool that can assist doctors in making faster, more accurate decisions about which patients need specialist dementia evaluation, potentially leading to earlier diagnosis and better patient outcomes.",[142,26,143,144,145,146,147,148,149],"Dementia (Diagnosis)","Vascular Dementia (VaD)","Lewy Body Dementia (LBD)","Frontotemporal Dementia (FTD)","Mild Cognitive Impairment (MCI)","Depression - Major Depressive Disorder","Stress","Cognitive Impairment",[151,152,153,154,155,156,157,158,159,144,145,146,160,161,162,163,149,164],"artificial intelligence","speech-based artificial intelligence","artificial intelligence in dementia diagnostics","artificial intelligence for dementia screening","artificial intelligence for dementia classification","speech based artificial intelligence","dementia","Vascular dementia (VaD)","Alzheimer dementia (AD)","Depression - Major Depressive disorder","Dementia (diagnosis)","machine learning","stress","deep learning","NOT_YET_RECRUITING","2026-04-28",{"date":168,"type":39},"2026-05-05",{"date":170,"type":21},"2026-06-01",{"date":172,"type":21},"2028-07",{"name":174,"class":46},"Zealand University Hospital",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":16,"sex":17,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":47},"100432111","genetic-studies-of-early-onset-dementia-100432111","NCT04906863","Genetic Studies of Early-onset Dementia","Inclusion criteria:\n\n* 35 years and older\n* Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.\n\nExclusion Criteria:\n\n\\- Individuals with competing diagnosis such as Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc., unless family members of a dementia affected individual","35 Years",{"count":183,"type":21},1000,"The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.",[186,26,146,187],"Dementia, Early Onset","Memory Loss",[65,189,190,191,192,27,193],"Memory loss","Early-onset Alzheimer's disease","Mild cognitive impairment","Normal cognition","Genetics","2026-04-24",{"date":196,"type":39},"2026-04-29",{"date":198,"type":39},"2016-09-14",{"date":200,"type":21},"2028-04-30",{"name":202,"class":46},"Columbia University",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":211,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":58,"phases":214,"briefSummary":215,"conditions":216,"keywords":222,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":47},"100614447","phase-2-fisetin-in-mild-alzheimers-disease-100614447","NCT07279714","Fisetin in Mild Alzheimer's Disease","Fisetin Intervention Study in Mild Alzheimer's Disease","FIS-AD","Inclusion Criteria:\n\n* Mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer Dementia\n* Moca score of 11 or higher\n* Stable psychotropics and cognitive enhancing medications\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to fisetin\n* Presence of any medical condition, or abnormal routine blood test, that the investigator believes would put the subject at risk or would preclude the patient from completing all aspects of the trial\n* Unstable medical disorders\n* Ongoing treatment for active infection with antibiotics\u002Fantifungals\n* Ongoing treatment for cancer\n* Active alcohol or substance use disorder\n* Recent active bleeding\n* Patients taking oral anticoagulants, anti-cancer, anti-seizure medications, or other medications that could have a significant interaction with fisetin\n* Use within the last month of other senolytic supplements, antioxidant supplements, natural health products\n* Other neurologic or neurodegenerative conditions impacting cognition\n* Active Major Depressive Episode, active suicidal thoughts or psychosis\n* Any thing that would preclude the ability to undergo an MRI scan","60 Years",{"count":213,"type":21},5,[61],"This pilot study will evaluate the safety and tolerability of the natural health product, fisetin, in older adults with mild cognitive impairment or mild Alzheimer's disease dementia.",[119,217,26,218,219,220,221],"Alzheimer Dementia","Alzheimer Disease","Mild Cognitive Disorder","Neurocognitive Disorders, Mild","Neurocognitive Disorder",[223,224,225,226],"fisetin","alzheimer's disease","safety","tolerability","2026-04-10",{"date":229,"type":39},"2026-04-13",{"date":231,"type":39},"2026-01-27",{"date":233,"type":21},"2026-11",{"name":235,"class":46},"Sunnybrook Health Sciences Centre",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":16,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":47},"100632625","predicting-pre-dementia-100632625","NCT07516119","Predicting Pre-dementia","Assessing Tools That Predict and Stage Mild Cognitive Impairment","Inclusion Criteria:\n\nAge\n\nAge 55 years or older at enrollment.\n\nAPOE Genotype\n\nDocumented carrier of at least one APOE ε4 allele, based on prior testing (e.g., clinical APOE testing, prior genetic panel, research cohort genotyping, or direct-to-consumer testing).\n\nExisting Genomic Data for PRS\n\nWhole-genome sequencing (WGS) data already completed, with willingness to provide existing WGS data files (e.g., VCF, FASTQ, or equivalent) to the study team for Alzheimer's disease polygenic risk score (PRS) calculation; or\n\nIf WGS is not available, prior high-density or targeted genotyping array data covering Alzheimer's disease risk loci, with willingness to provide these data for PRS calculation (feasibility of array-based PRS will be evaluated case-by-case).\n\nNote: The study does not perform APOE genotyping or WGS as part of the research; these must be completed before enrollment.\n\nCognitive Status at Baseline\n\nCognitively normal or very mildly impaired at baseline, defined by:\n\nDigital cognitive assessment and\u002For Punto Test consistent with a Global Clinical Dementia Rating (CDR) of 0 or 0.5.\n\nNo clinical diagnosis of dementia.\n\nFor cognitively normal (CN) and subjective cognitive decline (SCD) participants, staging by the Progression and Risk (P\\&R) model (combining PRS, biomarker, and cognitive data) will be applied for risk stratification.\n\nAbsence of Baseline AD-MCI by Biomarkers\n\nDoes not currently qualify for Alzheimer's disease-related MCI (AD-MCI), operationalized as no evidence of MCI with plasma or CSF pTau217 level above a validated cutoff for AD-MCI pathology.\n\nCapacity and Participation Ability\n\nAble to provide informed consent (with capacity assessments and, where applicable, involvement of a legally authorized representative per institutional policy and IRB approval).\n\nAble and willing to comply with study procedures, including clinic visits, cognitive testing, and biospecimen collection.\n\nWillingness to Use Digital Monitoring Tools\n\nWilling to wear and\u002For carry digital devices for continuous or frequent monitoring (e.g., smartphone app, wearable sensors such as Oura Ring, sleep device), and to participate in app-based cognitive and speech assessments.\n\nData-Sharing Authorizations\n\nWillingness to sign data release authorizations allowing the study to obtain existing genomic data (WGS or array) and relevant electronic medical record (EMR) data needed for risk modeling and outcome adjudication.\n\nExclusion Criteria:\n\nBaseline Dementia Diagnosis\n\nClinical diagnosis of dementia of any cause at baseline.\n\nMajor Neurological Disorders Affecting Cognition\n\nHistory of major neurological conditions that in the investigator's judgment may confound cognitive assessment or outcomes, such as:\n\nParkinson's disease.\n\nStroke with residual neurological deficits.\n\nEpilepsy with frequent seizures.\n\nMajor Psychiatric Illness\n\nMajor psychiatric disorders that significantly interfere with participation or data interpretability, such as uncontrolled major depressive disorder or schizophrenia, as judged by the investigator.\n\nSerious or Unstable Medical Conditions\n\nUncontrolled systemic medical illness expected to limit life expectancy to less than approximately 3 years, including but not limited to unstable cardiac, hepatic, or renal disease.\n\nRecent Investigational or Disease-Modifying AD Treatments\n\nUse of investigational drugs or disease-modifying Alzheimer's therapies within 6 months prior to baseline, if such treatments are likely to confound biomarker trajectories or cognitive outcomes.\n\nInability or Unwillingness to Use Required Digital Tools\n\nLack of Required Genomic Documentation or Refusal to Share Data\n\nNo prior APOE genotype documenting at least one ε4 allele; or\n\nNo available WGS or suitable genotyping array data; or\n\nRefusal to share existing APOE\u002Fgenomic data and necessary EMR data with the study team.\n\nBaseline MCI with Positive pTau217\n\nVulnerable Populations Not Targeted\n\nChildren, prisoners, and pregnant individuals are not specifically targeted and will be excluded from enrollment.","55 Years",{"count":245,"type":21},100,"The goal of this observational study is to learn how well a multimodal \"Progression and Risk\" (PR) model can predict and stage early mild cognitive impairment (MCI) due to Alzheimer's disease in cognitively normal or very mildly impaired ApoE4-positive adults aged 55 and older. The main questions it aims to answer are:\n\nCan a prespecified proteogenomic PR model accurately predict conversion from cognitively normal (CN) or very mildly impaired status to pTau217-positive MCI Stage I within 24 months in ApoE4-positive adults?\n\nDoes adding digital monitoring features (e.g., sleep, activity, speech), EMR-lifestyle risk scores, and plasma biomarkers to a polygenic risk score (PRS) meaningfully improve risk stratification and time-to-conversion prediction compared with simpler models (e.g., PRS alone or standard clinical risk factors)?\n\nIf there is a comparison group: Researchers will compare performance of the full multimodal PR model (integrating PRS, plasma proteomics and other omics, digital monitoring, and EMR-lifestyle data) with simpler or reduced models (for example, PRS-only, biomarker-only, or models without continuous digital monitoring) to see if the full model provides higher discrimination (AUC\u002FROC), better calibration, and improved time-to-conversion prediction for CN to pTau217-positive MCI transitions.\n\nParticipants will:\n\nProvide prior genomic data (ApoE genotype and whole-genome sequencing or high-density genotyping array data) for calculation of an ancestry- and sex-normalized Alzheimer's disease PRS and assignment to PRS-based risk strata.\n\nAttend an in-person baseline visit and follow-up visits at months 6, 12, 18, and 24 (±2 months) for clinical evaluation, neurocognitive testing (including CDR and digital cognitive batteries), and venous or capillary blood collection for plasma pTau217 and other AD biomarkers, proteomic and methylome panels, and routine safety labs when indicated.\n\nUse digital devices (e.g., Oura Ring and smartphone-based tools) for continuous or frequent remote monitoring of sleep, activity, heart rate metrics, mobility\u002Flocation, and speech-linked digital cognitive tasks, with adherence checks at study visits.\n\nUndergo optional or sub-cohort procedures as clinically indicated or as resources allow, such as EEG, retinal hyperspectral imaging, MRI, or amyloid PET, and optionally allow clinically indicated lumbar puncture CSF samples and external clinical data to be shared with the study for exploratory biomarker analyses.",[146,26,248,249],"Alzheimer Disease (AD)","APOE-4 Positive",[251,252,253,254,255],"Observational cohort preclinical Alzheimer's disease","ApoE4-positive cognitively normal adults 55+","Plasma pTau217 and blood biomarkers for MCI","Polygenic risk score and proteogenomic risk model","Digital cognitive assessment and Oura Ring monitoring","2026-03-31",{"date":258,"type":39},"2026-04-07",{"date":260,"type":21},"2026-04-15",{"date":262,"type":21},"2029-04-15",{"name":264,"class":46},"Prevention Research Consortium Corp.",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":16,"sex":17,"minAge":272,"maxAge":112,"enrollmentInfo":273,"targetDuration":4,"studyType":58,"phases":275,"briefSummary":276,"conditions":277,"keywords":287,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":47},"100632087","ultra-high-resolution-pet-in-aging-neurodegeneration-and-psychotic-disorders-100632087","NCT07509125","Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders","Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders","Inclusion Criteria:\n\n* WP1: Healthy controls\n* Age between 18 and 90 years old (15 aged 18-50 years and 25 aged 50 90 years);\n* Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests;\n* No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;\n* In subjects \\\u003C 60 years of age, a normal structural MRI scan as assessed by expert radiologist.\n* In subjects \\>= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score \\\u003C= 2 (of 3) on the Age-Related White Matter changes scale are acceptable;\n* When older than 50 years of age, the volunteer is willing to undergo a p- tau217 blood sample.\n* WP2: Dementia\n* Patient has a clinical diagnosis of biomarker-proven prodromal AD\n* WP3: ALS spectrum\n* Subject must meet El Escorial Criteria (30) and Awaji-Shima criteria (31) for at least possible ALS;\n* WP4: Movement disorders\n* (all): Patient (or legal representative, when applicable) is able to understand the patient information form and give written informed consent.\n* Parkinson´s disease (PD):\n* Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria (32);\n* Patient has an abnormal 18F-PE2I PET;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline.\n* Multiple system atrophy (MSA)\n* Patient has clinically established or clinically probable MSA-P based on the\n* Movement Disorder Society (MDS) diagnostic criteria (33);\n* Patient has an abnormal 18F-PE2I PET.\n* Progressive supranuclear palsy (PSP)\n* Patient has an abnormal 18F-PE2I PET;\n* Patient has clinically established probable PSP according to the latest MDS criteria\n* Dementia with Lewy bodies (DLB)\n* Patient has probable DLB by consensus criteria (cognitive impairment MoCA \\\u003C 26 + visual hallucinations and\u002For fluctuating alertness);\n* Patient has an abnormal 18F-PE2I PET.\n* Idiopathic REM sleep behavior disorder (iRBD)\n* Patient has Polysomnography-confirmed iRBD;\n* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;\n* No clinical evidence of parkinsonism at baseline.\n* WP5: Psychosis\n* DSM 5 criteria for a non-affective schizophrenia spectrum psychotic disorder;\n* Age between 18 and 55 years old for adult-onset psychosis, onset of psychosis (and age) above 60 years old for very late onset psychosis.\n\nExclusion Criteria:\n\n* Subject has a history of any major (other) internal, psychiatric or neurological disease that may interfere with the investigations (especially liver and kidney disease, uncontrolled diabetes, cancer, severe depression, stroke, severe TBI);\n* Subject is currently a user (including recreational use) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse;\n* Subject chronically uses medication that has central nervous system effects (e.g. strong painkillers such as opioids, neuroleptics,..; ) (other than prescribed for the illness in case of patients);\n* Subject has had exposure to ionizing radiation (\\> 1 mSv) in other research studies within the last 12 months;\n* Subject has a contra-indication for MRI scanning;\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for (at least) 60 minutes inside the scanner;\n* (For subjects with arterial sampling): The subject is hypersensitive to lidocaine (used for local anaesthesia during the placement of the arterial catheter), has an abnormal Allen test (a test to check blood flow in the arteries of the forearm) or is on anti-coagulant therapy;\n* Subject (or his\u002Fher legal representative) does not understand the study procedures;\n* Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;\n* Subject is potentially pregnant (hCG test can be done if doubt exists).","18 Years",{"count":274,"type":21},300,[90],"The goal of this study is to use ultra-high-resolution (UHR) PET imaging to better understand how the brain and spinal cord change in healthy aging and in neurological and psychiatric disorders such as Alzheimer's disease (AD), Parkinson's disease and related movement disorders, amyotrophic lateral sclerosis (ALS), and psychotic disorders. Researchers will use the NeuroExplorer PET\u002FCT system, a new scanner that can show very small structures in the brain and spinal cord in much more detail than regular PET.\n\nThe main questions this study aims to answer are:\n\n* How do small but important brain regions (like the locus coeruleus, substantia nigra, and thalamic nuclei) change in healthy aging?\n* What early brain changes occur in neurodegenerative and psychotic disorders, and can they help improve early diagnosis?\n\nParticipants will:\n\n* Undergo PET and MRI brain scans using different tracers that measure brain metabolism (18F-FDG), synaptic density (¹⁸F-SynVesT-1), dopamine transporters (¹⁸F-PE2I), and tau protein buildup (¹⁸F-MK6240).\n* Complete cognitive and clinical assessments related to memory, mood, and motor or psychiatric symptoms, depending on their group.\n\nThis study will include healthy volunteers and patients with mild cognitive impairment due to Alzheimer´s disease, ALS, Parkinson's disease and related disorders, or psychotic disorders.\n\nThe results will help create detailed brain imaging maps for healthy aging and identify early biomarkers for different diseases to support better diagnosis and treatment in the future.",[26,278,279,280,281,282,283,284,285,286],"ALS - Amyotrophic Lateral Sclerosis","Parkinson s Disease","REM Sleep Behavior Disorder (iRBD)","PSP - Progressive Supranuclear Palsy","MSA - Multiple System Atrophy","Dementia With Lewy Bodies (DLB)","ALS With Frontotemporal Dementia (ALS\u002FFTD)","Adult Onset Psychotic Disorder","Very Late Onset Psychotic Disorder",[288,289,27,290,291,292,293,294,295,296,297,298,299,300,301,302],"PET\u002FCT scan","Alzheimer´s disease","Amyotrophic Lateral Sclerosis","Parkinson´s disease","REM sleep behavior disorders","Progressive supranuclear palsy","Multiple System Atrophy","Dementia with Lewy Bodies","Psychotic disorders","Schizophrenia","ALS with frontotemporal dementia","UHR PET","Locus coeruleus","Papez circuit","Thalamic subnuclei","2026-03-27",{"date":305,"type":39},"2026-04-03",{"date":307,"type":39},"2026-02-13",{"date":309,"type":21},"2029-09",{"name":311,"class":46},"Universitaire Ziekenhuizen KU Leuven",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":16,"sex":17,"minAge":211,"maxAge":112,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":47},"100630007","brain-blood-flow-and-sugar-transport-in-alzheimers-disease-with-and-without-diabetes---a-pilot-imaging-study-100630007","NCT07482072","Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study","Imaging Biomarkers in Alzheimer's Disease - an Exploratory PET Study","PETTAU","Inclusion Criteria:\n\n* suspected Alzheimer's disease\n* type 2 diabetes (group A)\n* able and willing to comply with study protocoil´´l\n\nExclusion Criteria:\n\n* type 2 diabetes (group B and C)\n* significant brain disease apart from dementia (group A and B)\n* significant vascular or neurological disease (group C)\n* active cancer treatment\n* history of alcohol or drug abuse\n* severe claustrophobia\n* pregnancy or breastfeeding",{"count":321,"type":21},60,"Alzheimer's disease is the most common cause of dementia and affects a growing number of older adults. Although harmful proteins build up in the brain, we still do not fully understand why some brain regions are affected earlier or more severely than others. Many people with Alzheimer's disease also have problems with blood flow and sugar handling in the brain, and these changes may play an important role in disease development. People with type 2 diabetes are at especially high risk of developing Alzheimer's disease and often experience a more severe disease course.\n\nThis pilot study aims to improve our understanding of how brain blood flow and sugar use are altered in Alzheimer's disease, and whether these changes differ in people with and without type 2 diabetes. We will study three groups: people with Alzheimer's disease without diabetes, people with Alzheimer's disease and type 2 diabetes, and healthy older individuals. By comparing these groups, we aim to identify early brain changes that may contribute to cognitive decline.\n\nParticipants will undergo advanced brain imaging using positron emission tomography (PET) scans. One scan uses a radioactive sugar tracer to measure how the brain takes up and uses glucose. Importantly, a new non-invasive method will also allow us to estimate how efficiently glucose is transported from the blood into the brain. This is a key process that may be impaired in Alzheimer's disease, but has previously required invasive procedures. The new approach avoids arterial cannulation, making the study safer and more comfortable for participants.\n\nA second PET scan will assess brain blood flow and blood vessel function, including how well the vessels can respond to increased demand. Participants will also complete cognitive tests to assess memory and thinking abilities.\n\nUltimately, this research may contribute to earlier diagnosis, better monitoring of disease progression, and development of new treatment strategies for Alzheimer's disease.",[26,324],"Diabete Type 2",[326,327,328,329,330],"neuroimaging","Alzheimer's disease","amyloid","glucose transport","glucose metabolism","2026-03-13",{"date":333,"type":39},"2026-03-19",{"date":335,"type":21},"2026-03",{"date":337,"type":21},"2026-12",{"name":339,"class":46},"Rigshospitalet, Denmark",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":17,"minAge":347,"maxAge":112,"enrollmentInfo":348,"targetDuration":4,"studyType":58,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":47},"100628040","making-antibody-treatments-more-effective-in-early-alzheimers-disease-using-3tesla-magnetica-resonance-100628040","NCT07456462","Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance","Precision Monitoring and Predictive Models for Optimizing Monoclonal Antibody Therapy in Early Alzheimer's Disease - A Prospective Monocenter Interventional Study on 3T MRI","Inclusion Criteria:\n\n1Participant is willing and able to give informed consent for participation in the study.\n\n2\\. Participant is eligible for anti-amyloid therapy (AAT), i.e.:\n\n* Participants aged 30-90.\n* Diagnosis of early symptomatic AD, including MCI or mild dementia \\[2\\].\n* Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0\n* Confirmed amyloid pathology through CSF or PET imaging. 3. Participant is willing to start Anti-amyloid therapy as part of his\u002Fher clinical-practice- therapeutic plan.\n\n  4\\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional four weeks after the end of study.\n\n  5\\. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n\nExclusion Criteria:\n\n* 1\\. Contraindications to AAT, including:\n\n  * Significant neurological diseases other than AD that could affect cognition or study participation (e.g., other dementias, serious brain infections, Parkinson's disease, multiple concussions, epilepsy with recurrent seizures).\n  * Homozygous ApoE4 genotype.\n  * Current use of anticoagulant therapy.\n  * Vascular abnormalities: Presence of more than 4 microhemorrhages (defined as ≤10 mm in greatest diameter), a single macrohemorrhage \\>10 mm, superficial siderosis, evidence of vasogenic edema, multiple lacunar infarcts, or stroke involving a major vascular territory.\n  * Amyloid-Related Imaging Abnormalities (ARIA): Evidence of ARIA, including cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid beta-related angiitis (ABRA).\n  * Bleeding disorders: History of bleeding disorders not under adequate control, including a platelet count \\\u003C50,000 or international normalized ratio (INR) \\>1.5 for participants not on anticoagulant therapy.\n  * Being currently under treatment with another AAT other than lecanemab\u002Fdonanemab (e.g. as part of a Clinical Trial).\n\n    2\\. Current serious or unstable illnesses, including:\n  * Cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic diseases.\n  * Conditions that, in the clinician's opinion, could interfere with study analyses or with a life expectancy of less than 24 months.\n  * History of cancer within the last 5 years, except for non-metastatic basal and\u002For squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence.\n\n    3\\. Inability to undergo MRI or PET imaging procedures (e.g. non-MRI safe pacemaker or devices, claustrophobia etc).\n\n    4\\. Women of childbearing potential who are not using adequate contraception, as well as pregnant or breastfeeding women.","30 Years",{"count":349,"type":21},50,[90],"Alzheimer's disease causes progressive memory and cognitive decline, driven in part by the buildup of a protein called β-amyloid in the brain. New antibody therapies - lecanemab and donanemab - can remove amyloid and slow down the disease in its early stages. However, it is still unclear how long each patient should continue treatment or when it is safe to stop, because amyloid is cleared at different rates across individuals.\n\nToday, amyloid Positron Emission Tomography (PET) scans are used to measure whether amyloid has been removed from the brain, but these scans are expensive, not always available, and expose patients to radiation. Since repeated PET scans are not ideal, doctors need better ways to monitor treatment progress.\n\nThis study will use advanced brain Magnetic Resonance Imaging (MRI) and blood tests to create personalized prediction models. These models will simulate how amyloid spreads or clears in each person's brain and help identify when treatment is still needed. With this approach, monitoring becomes safer, more efficient, and more affordable - helping ensure that each patient receives the right treatment for the right amount of time.\n\nThis prospective monocenter study investigates the role of 3Tesla MRI-based predictive modeling in predicting treatment response to anti-amyloid monoclonal antibodies (lecanemab or donanemab administered as clinical practice) in 50 patients with early Alzheimer's disease (AD) at IRCCS Ospedale San Raffaele (Milan, Italy). Advanced MRI techniques, including high- resolution structural imaging for cortical thickness and volumetric atrophy, diffusion imaging for structural connectivity, and resting-state functional MRI for functional network analysis, will be acquired at baseline, 6, 12, and 18 months.\n\nThese multimodal MRI measures will be integrated into computational approaches, such as the Aggregation Network Diffusion (AND) model, to simulate individual disease trajectories and predict the probability of achieving negativity at amyloid PET under treatment.\n\nWhile serial \\[¹⁸F\\]Flutemetamol PET will be performed as part of standard clinical practice to confirm amyloid removal, the focus of the study is on developing MRI- derived predictive biomarkers. The ultimate goal is to establish robust, non-invasive models capable of guiding individualized treatment monitoring and supporting evidence-based decisions on treatment discontinuation\n\nOverall, the project aims to support more precise care for people with early Alzheimer's disease, while reducing unnecessary procedures and improving quality of life.",[26,146],[327,354,355,356,357,358,359,360,361,362],"Amyloid","Monoclonal antibody therapy","Lecanemab","Donanemab","Precision medicine","Predictive modeling","3 Tesla Magnetic Resonance","Amyloid Tomography Emission Positron (PET)","Plasma biomarkers","2026-03-03",{"date":365,"type":39},"2026-03-06",{"date":99,"type":21},{"date":368,"type":21},"2029-05-01",{"name":370,"class":46},"IRCCS San Raffaele",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":17,"minAge":211,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":58,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":47},"100626122","dementia-and-storytelling-in-vietnam-100626122","NCT07431528","Dementia and Storytelling in Vietnam","Digital Storytelling to Promote Early Dementia Diagnosis in Rural Vietnam","Inclusion Criteria:\n\n* Older adults (age ≥ 60 years) residing in one of the four participating communities (communities in rural areas of Phu Tho province with minimum distance of 10 km between participating communities)\n* Concern about mild cognitive impairment expressed by the participant, caregiver, or healthcare provider, with no formal screening for ADRD\n* Ability and willingness to provide informed consent\n* Caregivers of eligible participants will be invited to participate after providing written consent.\n\nExclusion Criteria:\n\n* Current participation in another ADRD study\n* Severe cognitive impairment as evaluated by study co-investigators\n* Enrollment in palliative care or diagnosis of a terminal illness\n* Previous exposure to digital storytelling modules\n* Prior participation in the digital storytelling development.",{"count":245,"type":21},[90],"This project aims to improve knowledge regarding Alzheimer's dementia and related dementias (ADRD) among older adults and their caregivers in Vietnam and promote the early diagnosis of ADRD using a digital storytelling intervention.",[26],[383,384,385,386,387],"Storytelling intervention","mHealth","Early detection","Rural health","Vietnam","2026-02-18",{"date":390,"type":39},"2026-02-24",{"date":392,"type":21},"2026-10-01",{"date":101,"type":21},{"name":395,"class":46},"University of Massachusetts, Worcester",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":404,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":58,"phases":407,"briefSummary":409,"conditions":410,"keywords":417,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":438,"locationsCount":213},"100610985","phase-3-levetiracetam-to-prevent-seizures-in-symptomatic-alzheimers-disease-in-adults-with-down-syndrome-100610985","NCT07234695","LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome","A Phase III, Randomized, Double-blinded Study of the Efficacy and Safety of LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome (the LESS-AD Trial).","LESS-AD","Inclusion Criteria:\n\n* Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype.\n* Age over 40 years at time of screening.\n* Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off points will be established to diagnose dementia depending on the level of intellectual disability of the individual, according to previous experience (Benejam et al; 2020): in adults with mild intellectual disability, a CAMCOG-DS score of 80 and an mCRT score of 29 will be chosen, whereas values of 56 and 28, respectively, will be used in subjects with moderate intellectual disability. Doubtful cases (e.g., with compromised functionality, but without alteration in the neuropsychological assessment) or those unable to complete the evaluation will be categorized by consensus among expert clinicians, using all available clinical information.\n* Willing and able caregiver who has daily contact with the study subject.\n* Subjects and caregivers must be able to comply with the prescribed regimen of study treatment throughout the course of the study and meet a minimum required time commitment of biannual in-person visits.\n* Any concurrent treatment for AD approved by the European Medicines Agency (EMA) must be stable for at least 30 days prior to screening and at least 60 days prior to study day 1. Other medications (except for those listed under exclusion criteria) are allowed as long as the dose is stable for 30 days prior to screening.\n* Subjects and\u002For their caregivers must be able to provide their consent before participating in any study-related procedures.\n\nExclusion Criteria:\n\n* Cognitive changes attributable to causes other than AD (for example, but not limited to, uncorrected visual or hearing deficit, severe, untreated sleep apnea or uncontrolled thyroid disorders).\n* Previous history of adult-onset epileptic seizures (over 18 years old).\n* Treatment with any kind of antiepileptic drugs, benzodiazepines, narcotics.\n* Significant comorbidities or analytical abnormalities, such as:\n* Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of the study (eg, moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.\n* Severe renal dysfunction (creatinine clearance \\\u003C 30 mL\u002Fmin), which would affect serum levetiracetam levels, or any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse effect.\n* Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks \\[TIAs\\]).\n* Significant risk of suicide, defined using the C-SSRS as the subject answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 12 months.\n* Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.\n* Participation in another clinical trial within 3 months of screening.\n* Hypersensitivity to the active ingredient, other pyrrolidone derivatives, or any of the excipients\n* Pregnant and breastfeeding patients","40 Years",{"count":406,"type":21},120,[408],"PHASE3","The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease.\n\nPatients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo.\n\nBoth groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.",[411,412,413,217,26,218,248,414,415,416],"Down Syndrome","Down Syndrome (DS)","Down Syndrome (Trisomy 21)","Alzheimer Blood Biomarkers","Epilepsy","Seizures",[418,419,420,157,421,422,423,424,425,426,427,428,429,430,431],"Down syndrome","epilepsy","Alzheimer","levetiracetam","prevention","placebo-controlled","epileptic seizures","Alzheimer&#39;s disease markers","phase III","randomized","double-blind","bilateral tonic-clonic seizure","217-pTau","NfL","2026-01-08",{"date":434,"type":39},"2026-01-12",{"date":436,"type":21},"2025-12-22",{"date":172,"type":21},{"name":439,"class":46},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":58,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":47},"100615165","positive-psychology-for-early-cognitive-decline-effects-on-cognitive-and-brain-function-100615165","NCT07289061","Positive Psychology for Early Cognitive Decline: Effects on Cognitive and Brain Function","Application of Positive Psychology Interventions in Individuals With Early-stage Cognitive Decline Related to Dementia: Their Impact on Cognitive and Brain Functioning","Inclusion Criteria\n\n-Documented diagnosis of Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) according to clinical evaluation and site standard criteria.\n\nExclusion Criteria\n\n* Diagnosis of dementia (major neurocognitive disorder) or other major neurocognitive disorder that is moderate or severe.\n* Major psychiatric disorder currently unstable or untreated (e.g., major depression with psychotic features, bipolar disorder, schizophrenia).\n* Neurological conditions that affect cognition.\n* Uncorrected hearing or vision problems that prevent participation in assessments or online sessions.\n* Concurrent participation in another interventional study targeting cognition or wellbeing during the study period.",{"count":448,"type":21},128,[90],"This randomized study tests whether a new multicomponent Positive Psychology program can improve cognition and wellbeing in older adults at the earliest stages of dementia-related decline.\n\nAbout 128 participants with Subjective Cognitive Decline or Mild Cognitive Impairment will be enrolled. Half will be randomized to the Positive Psychology program and half to Treatment As Usual (TAU).\n\nThe program consists of weekly, small-group online sessions for \\~24 weeks plus brief home practices. All participants (both arms) will complete questionnaires and cognitive tests at baseline, during treatment, post-treatment, and 9-month follow-up.\n\nPrimary question: Do participants receiving the Positive Psychology program show better cognitive and brain-function outcomes than TAU at post-treatment and at 9 months? Secondary question: Are effects larger for SCD than MCI? No medicines are used and risks are minimal. If effective, this scalable, low-cost, non-pharmacological approach could complement usual care for people in very early cognitive decline.",[452,146,26],"Subjective Cognitive Decline (SCD)",[454,455,456,457,458,459,460,224],"positive psychology","non-pharmacological intervention for dementia","character strengths","mindfulness","forgiveness","gratitude","humor","2026-01-06",{"date":463,"type":39},"2026-01-07",{"date":465,"type":39},"2025-12-17",{"date":467,"type":21},"2027-07",{"name":469,"class":46},"Aristotle University Of Thessaloniki",{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":477,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":58,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":47},"100609707","phase-1-a-trial-to-test-intermittent-deep-brain-stimulation-of-nucleus-basalis-of-meynert-to-treat-alzheimers-100609707","NCT07218081","A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.","Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.","Inclusion Criteria:\n\n* Age:65 minimum\n\n  * Age:85 maximum\n  * Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteria and positive PET for beta amyloid,\n  * no Lewy-Body-dementia or other form of dementia\n  * Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a CBR-sb score from 2 to 6.\n  * MMSE ≥ 21\n  * stable psychopharmacological medication equivalent to 10 mg\u002Fday donepezil or less for at least 60 days\n  * valid informed consent\n  * an available caregiver willing to participate\n  * subject is living at home and likely to remain at home for the study duration\n  * Geriatric Depression Scale of 5 or less\n  * Columbia Suicide Severity Rating Scale \"No\" on questions 3 through 5\n  * Neuropsychiatric Inventory (NPI-Q) under 2 on 'Delusions', 'Hallucinations' or 'Agitation\u002FAggression' subscales\n\nExclusion Criteria:\n\n* • clinical co-morbidity interfering with study (e.g. head trauma requiring medical treatment in the 2 years prior, brain tumor, subdural hematoma, or other clinically significant space-occupying lesion on brain CT or MRI), or other implant precluding high field MRI scans.\n\n  * current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit, or past medical history prior suicidal attempts or suicidal crises\n  * Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).\n  * Medical history of seizure disorder including epilepsy\n  * Terminal illness associated with expected survival of \\\u003C30 months\n  * Subjects with one of these other forms of dementia in the DSM-5 heading of Neurocognitive Disorders: Lewy body disease, Frontotemporal lobar degeneration, Vascular disease, Traumatic brain injury, HIV infection, Prion disease, Parkinson's disease, Huntington's disease, or due to multiple etiologies\n  * Subjects with unstable medical and neurological conditions at the discretion of the Principle Investigator","65 Years","85 Years",{"count":480,"type":21},12,[60],"The purpose of this study is to test a new procedure to treat Alzheimer's disease. The procedure is called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert. There will be up to six participants enrolled at Wellstar MCG Memory Clinic. There will be another six participants similarly enrolled to act as a control group that does not receive DBS. This second group will document the course of progression of Alzheimer's disease under the normal standard of care. The main goal of the study is to determine if DBS can sustain or improve cognition in Alzheimer's disease for at least two years. Participant data, with identifying information removed, may be shared with online repositories for comparison with trials with similar subjects.",[26],[485,486,487],"deep brain stimulation","alzheimer's","nucleus basalis of Meynert","2026-01-05",{"date":463,"type":39},{"date":491,"type":21},"2026-02-01",{"date":493,"type":21},"2028-11",{"name":495,"class":46},"Augusta University",{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":58,"phases":505,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":47},"100614449","phase-2-combined-brain-stimulation-and-methylphenidate-treatment-for-apathy-in-dementia-100614449","NCT07279740","Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia","Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders","PRIME","Inclusion Criteria:\n\n* Alzheimer's disease or mixed Alzheimer's disease and vascular disease\n* MMSE score 10-28 inclusive\n* Clinically significant apathy\n* Stable dose of psychotropic medication\n* Care partner must spend at least 10hrs\u002Fweek with the participant\n\nExclusion Criteria:\n\n* Major Depressive Episode\n* Clinically significant agitation, delusions, hallucinations\n* Currently talking a dopaminergic agent other than methylphenidate\n* Failure to clear the TMS adult safety scale (e.g. unapproved pacemakers, metallic implants, history of epilepsy)\n* Central nervous system abnormalities (other than Alzheimer's disease) deemed clinically significant by study physician or seizures\n* Any condition that in the opinion of the study physician, makes it medically unsafe for the patient to enroll in the trial",{"count":480,"type":21},[61],"This study evaluates whether the combined treatment of methylphenidate and non-invasive brain stimulation, called intermittent theta burst stimulation, can effectively treat apathy in individuals with Alzheimer's disease or mixed AD\u002Fvascular dementia",[119,26,217,218,508,509],"Apathy","Apathy in Dementia",[511,157,327,512,513,514,515,516],"apathy","methylphenidate","rTMS","iTBS","repetitive transcranial magnetic stimulation","intermittent theta burst stimulation","2025-12-11",{"date":519,"type":39},"2025-12-12",{"date":521,"type":21},"2026-01",{"date":523,"type":21},"2027-10-01",{"name":235,"class":46},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":478,"enrollmentInfo":533,"targetDuration":4,"studyType":58,"phases":535,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":47},"100609128","phase-1-safety-of-nrtis-for-alzheimers-therapeutic-advancement-in-singapore-study-100609128","NCT07210528","Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study","A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Emtricitabine and Descovy in Patients With Mild Cognitive Impairment.","SONATAS","Inclusion Criteria:\n\n* MMSE score of 24 or above.\n* CDR-GS of 0 or 0.5 (calculated by the QDRS)\n* Diagnosed with MCI, determined by impairment in at least one domain of the neuropsychological test battery without significant dysfunction in activities of daily living OR MCI consistent with the NIA\u002FAA diagnostic criteria.\n* Does not have any medical condition (e.g. cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.\n* Willingness to provide blood sample and neuropsychological testing for the study.\n* Ability for the patient to provide informed consent.\n\nExclusion Criteria:\n\n* Patient who is receiving a prescription of acetylcholinesterase inhibitor (AChEI) and\u002For Memantine at screening or baseline.\n* Patients with a history of HIV or HBV infection, or that test positive for HIV or HBV on screening.\n* Pre-existing comorbidities such as Hepatits, cardiovascular disease, or renal insufficiency.\n* History of Moderate to severe hepatic impairment indicated by screening AST or ALT \\> 3x the upper limit of normal (ULN) or total bilirubin \\> 2x ULN.\n* Patients with severe renal impairment, or creatinine clearance ≤ 30 mL\u002Fmin (calculated by Cockcroft-Gault formulae at screening).\n* Co administration of nephrotoxic drugs.\n* Current or previous RTi use within the last 2 years.\n* Malignant neoplasm, and are undergoing active treatment.\n* Participating in other interventional clinical trials during the course of the study.\n* Documented history of lactic acidosis and severe hepatomegaly with steatosis.\n* Documented history of osteoporosis.",{"count":534,"type":21},48,[60],"Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD.\n\nThis identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets.\n\nThis proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention.\n\nThis study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers.\n\nParticipants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period.\n\nThe investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.",[146,26],[539,146,540,541,542],"Reverse Transcriptase Inhibitors","Descovy","Emtricitabine","Alzheimer&#39;s Disease (AD)","2025-09-29",{"date":545,"type":39},"2025-10-07",{"date":547,"type":39},"2025-06-30",{"date":549,"type":21},"2026-04",{"name":551,"class":46},"National University Hospital, Singapore",{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":17,"minAge":211,"maxAge":112,"enrollmentInfo":560,"targetDuration":4,"studyType":58,"phases":562,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":47},"100603993","phase-2-transcranial-pulse-stimulation-for-alzheimers-disease-100603993","NCT07143734","Transcranial Pulse Stimulation for Alzheimer's Disease","A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects","TPS","Inclusion Criteria:\n\n* Adults who have been clinically diagnosed with Alzheimer's Disease in the early stage 2-6a according to the Functional Assessment Staging Test (In Appendix A)\n* The mental capacity to give informed consent for research is made by an experienced geriatrician based on Appendix A.\n* Aged 60-90 years old.\n* Able to make informed consent under assistance, which is witnessed and signed by a family caregiver.\n\nExclusion Criteria:\n\n* Cannot understand Chinese.\n* Mentally incapacitated, unable to provide informed consent\n* Inability to remain still for 30 minutes\n* Lack of available family caregiver to answer questionnaires\n* Alcohol or substance dependence\n* Major neurological conditions, including:\n* Brain tumor\n* Brain aneurysm\n* Presence of any metal implants in the brain\n* Hemophilia or other blood clotting disorders\n* History of thrombosis",{"count":561,"type":21},40,[61],"TPS is a non-invasive therapeutic modality that uses focused, low-energy pulse stimulation to stimulate tissue regeneration and reduce inflammation. In the context of neurological disorders, it is hypothesized that TPS can modulate neuronal activity, enhance synaptic plasticity, and reduce neuroinflammation. It is a relatively new application in neurological disease treatment and is still under intense investigation.",[26],[566,26],"Transcranial Pulse Stimulation (TPS)","2025-09-15",{"date":569,"type":39},"2025-09-16",{"date":571,"type":39},"2025-07-21",{"date":573,"type":21},"2026-06",{"name":575,"class":46},"Chinese University of Hong Kong",{"id":577,"slug":578,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":16,"sex":17,"minAge":272,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":58,"phases":584,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":47},"100605209","music-listening-impact-on-quality-of-life-brain-and-burnout-of-alzheimer-patients-informal-caregivers-100605209","NCT07159542","MUSic Listening Impact on QUality of Life, Brain and Burnout of ALzheimer' Patients Informal Caregivers","MUSIQUAL+","Inclusion Criteria:\n\n* Native language: French\n* Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:\n\n  * Informal Caregivers: Being a carer for someone with neurodegenerative cognitive disorders (NCD), living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.\n  * Patients with neurodegenerative cognitive disorders: presenting neurodegenerative cognitive disorders, have an identified informal caregiver.\n\nExclusion Criteria:\n\n* A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint\n* A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);\n* A medication that may interfere with memory or metabolic measures",{"count":88,"type":21},[90],"Although life expectancy is increasing, the risk of dependence and\u002For loss of autonomy is increasing too with ageing. Alzheimer's disease affects many people and this kind of disease is constantly growing. Today, relatives of these sick people are increasingly taking on the role of carer to help them remain at home as long as possible. This situation of assistance has often a negative impact on the quality of life of the caregiver, which in some cases can lead to the caregiver burnout and increase the risk factors for developing pathological ageing. This situation can also damage the relationship and the quality of interactions between patient\u002Fcaregiver dyad. Non-pharmacological therapies and the use of digital tools appear to be promising avenues to fight psychological distress and social isolation, but also to improve the quality and duration of homecare services, by promoting the autonomy of the patient. The MUSIQUAL+ study aims to evaluate the impact of music listening offered to caregivers, alone or with their sick relative, on the quality of life and the exhaustion felt by the caregiver. Three times 20-minute sessions a week of music listening at home through the use of a tablet application, for 12 weeks, will be proposed. In addition to the collection of subjective feelings of the caregivers, a neuropsychological evaluation of the patient and the caregiver will be carried out on 90 dyads divided. Finally, in order to better understand the cerebral mechanisms involved and to provide evidence of the effect of this intervention, an EEG recording will be made before and after the musical listening. This study proposes a therapeutic and preventive alternative to drug treatments and to the currently unsatisfactory support of patients and their caregivers in distress; its benefits will be assessed too.",[26,587],"Caregivers",[587,589,420],"Music intervention","2025-09-05",{"date":592,"type":39},"2025-09-08",{"date":594,"type":21},"2025-09",{"date":596,"type":21},"2027-12",{"name":598,"class":46},"University Hospital, Caen",{"id":600,"slug":601,"hasResults":11,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":17,"minAge":605,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":58,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":4},"100601804","phase-2-plans4care-personalized-dementia-care-on-demand-100601804","NCT07115251","Plans4Care: Personalized Dementia Care on Demand","Inclusion Criteria:\n\n1. A family, friend, or neighbor who self-identifies as having primary care responsibilities for a person with memory loss;\n2. \\>21 years of age;\n3. Able to use an internet capable device (computer, tablet or smart phone), and have stable internet access;\n\n6\\. Actively (e.g., past 6 months) managing a dementia-related care challenge.","21 Years",{"count":607,"type":21},160,[61],"The Plans4Care study is a research study funded by the National Institute on Aging (Grant# R44AG084365). The Plans4Care app is designed to help family caregivers address over 90 common care challenges such as behavioral symptoms (anxiety, agitation), functional changes and other concerns, and receive an action plan which provides easy-to-use non-drug strategies, resources, tips and education.\n\nThe goal of the study is to evaluate whether using the Plans4Care app will help you feel more confident providing care to your family member with dementia, better understand dementia, and enhance your own well-being. You also have the option to talk with a care advisor who can practice use of strategies or address concerns you may have.",[27,611,26,187],"Dementia Alzheimer Type",[613],"Caregiver, Dementia, Memory Loss, Alzheimer","2025-08-04",{"date":616,"type":39},"2025-08-11",{"date":618,"type":21},"2025-08-30",{"date":620,"type":21},"2027-09-30",{"name":622,"class":623},"Plans4Care Inc","INDUSTRY",{"id":625,"slug":626,"hasResults":11,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":11,"sex":17,"minAge":272,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":47},"100509323","investigating-genetic-status-in-patients-presenting-to-clinic-100509323","NCT05911932","Investigating Genetic Status in Patients Presenting to Clinic","Inclusion Criteria:\n\n* Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);\n* Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;\n* Age 18+ years old;\n* Consenting to a blood draw.\n\nExclusion Criteria:\n\n• Persons declining \u002F unwilling \u002F not able to have a blood draw.",{"count":183,"type":21},"The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.",[633,26,144],"Dementia, Frontotemporal",[635],"Neurodegenerative disorders","2025-03-03",{"date":638,"type":39},"2025-03-04",{"date":640,"type":39},"2023-10-20",{"date":642,"type":21},"2043-08",{"name":644,"class":46},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":16,"sex":17,"minAge":211,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":4},"100541460","a-genetic-study-for-alzheimer-dementia-case-control-study-100541460","NCT06330155","A Genetic Study for Alzheimer Dementia: Case-control Study","1. Inclusion Criteria: Alzheimer's dementia patient\n\n   * Adult patients over 60 years old\n   * Patients with a Alzheimer's dementia patient\n   * Total Korean version of mini-mental state examination (K-MMSE) score less than 24\n   * Total Clinical Dementia Rating (CDR) over 0.5\n2. Inclusion Criteria: healthy subjects\n\n   * Adult healthy over 60 years old\n   * Total Korean version of mini-mental state examination (K-MMSE) over 24\n   * Total Clinical Dementia Rating (CDR) is 0\n3. Exclusion Criteria:\n\n   * Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition\n   * In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian\n   * Other cases where the researcher determines that participation in this clinical trial is not appropriate (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)",{"count":652,"type":21},20,"The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.\n\nThe investigators want to identify genes that are importantly related to Alzheimer's dementia.",[26],"2024-04-02",{"date":657,"type":39},"2024-04-04",{"date":659,"type":21},"2024-03-26",{"date":661,"type":21},"2026-12-31",{"name":663,"class":46},"MinYoung Kim, MD, PhD"]