[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimer-dementia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimer-dementia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,82,112,157,179,210,235,257,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100356862","electroconvulsive-therapy-ect-for-agitation-in-dementia-ad-100356862",false,"NCT03926520","Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)","Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia","ECT-AD","Inclusion Criteria\n\n1. Diagnosis of Dementia, of the following subtypes,\n\n   1. Alzheimer's dementia, according to NIA-AA Criteria for dementia\n   2. Vascular dementia based on:\n\n   i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies\n2. Mini Mental Status Exam (MMSE) less than or equal to 15\n3. Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, or intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).\n4. At least one failed pharmacological intervention to manage behavioral symptoms\n5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated\n6. Comprehension of English language\n7. Authorized legal representative able and willing to give informed consent\n8. Age 40 and above\n\nExclusion Criteria:\n\n1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis\n2. Diagnosis of vascular dementia due to stroke, based on:\n\n   * History consistent with abrupt onset and step-wise progression of cognitive and functional decline\n   * MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke\n   * Physical and neurologic examination consistent with current or prior stroke\n3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder\n4. Active substance use disorder within past 6 months\n5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months","ALL","40 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability\u002Fsafety outcomes of ECT+UC.",[27,28],"Alzheimer Dementia","Agitation,Psychomotor",[30,31,32,33],"ECT","Agitation","Alzheimer's","Dementia","RECRUITING","2026-04-24",{"date":37,"type":38},"2026-04-28","ACTUAL",{"date":40,"type":38},"2021-01-28",{"date":42,"type":21},"2026-05-31",{"name":44,"class":45},"Brent Forester","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"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":46,"type":21},[58],"PHASE2","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.",[61,27,62,63,64,65,66],"Alzheimer s Disease","Alzheimer Dementia (AD)","Alzheimer Disease","Mild Cognitive Disorder","Neurocognitive Disorders, Mild","Neurocognitive Disorder",[68,69,70,71],"fisetin","alzheimer's disease","safety","tolerability","2026-04-10",{"date":74,"type":38},"2026-04-13",{"date":76,"type":38},"2026-01-27",{"date":78,"type":21},"2026-11",{"name":80,"class":45},"Sunnybrook Health Sciences Centre",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":81},"100631777","efficacy-of-lecanemab-at-different-therapeutic-doses-for-alzheimers-disease-ad-in-real-world-practice-100631777","NCT07505095","Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice","Inclusion Criteria:\n\n* Meet the diagnostic criteria for AD-derived MCI or early AD \\[Clinical rating: CDR 0.5 (MCI) \u002F 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology\\]\n* Male or female\n* 50-85 years old\n* Not currently participating in other research studies\n* Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form\n* Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study\n\nExclusion Criteria:\n\n* Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.\n* Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.\n* Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.\n* Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.\n* Effects of drugs\u002Ftoxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.","50 Years","85 Years",{"count":91,"type":21},140,"18 Months","OBSERVATIONAL","This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.",[96,27,97],"Alzheimer Disease (AD)","MCI-AD, Early Stage Alzheimer's Disease",[99,100,101],"Alzheimer's Disease","lecanemab","different doses","NOT_YET_RECRUITING","2026-03-26",{"date":105,"type":38},"2026-04-01",{"date":107,"type":21},"2026-04-30",{"date":109,"type":21},"2028-01-31",{"name":111,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":132,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":46},"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",{"count":121,"type":21},120,[123],"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.",[126,127,128,27,62,63,96,129,130,131],"Down Syndrome","Down Syndrome (DS)","Down Syndrome (Trisomy 21)","Alzheimer Blood Biomarkers","Epilepsy","Seizures",[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"Down syndrome","epilepsy","Alzheimer","dementia","levetiracetam","prevention","placebo-controlled","epileptic seizures","Alzheimer's disease markers","phase III","randomized","double-blind","bilateral tonic-clonic seizure","217-pTau","NfL","2026-01-08",{"date":150,"type":38},"2026-01-12",{"date":152,"type":21},"2025-12-22",{"date":154,"type":21},"2028-07",{"name":156,"class":45},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":89,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":81},"100485843","phase-1-innate-immunity-stimulation-via-tlr9-in-early-ad-100485843","NCT05606341","Innate Immunity Stimulation Via TLR9 in Early AD","Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)","Inclusion Criteria:\n\n1. 65-85 years of age\n2. MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018\n3. Montreal Cognitive Assessment (MoCA) score ≥17 AND;\n4. Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment\n5. Must be able to provide consent or assent (If applicable).\n6. Must be willing and able to participate in all study related procedures.\n7. Must have a reliable study partner to provide information on the subject's cognitive and functional status. Study partner must have sufficient contact with the subject, as determined by the PI, and be available to accompany the subject to clinic visits or by phone.\n\nExclusion Criteria:\n\n1. History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study related procedures as determined by PI\n2. History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI\n3. Use of corticosteroids or immunosuppressive drugs within 30 days of study entry\n4. History of splenectomy\n5. Renal impairment\n6. Use of chloroquine within 8 weeks of study entry\n7. Inability to undergo MRI imaging\n8. History of TIA, stroke or seizures within 12 months of screening\n9. Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible \"long COVID\") as determined by PI\n10. Participation in any other current AD investigational interventional trial\n11. Current use of an anti-coagulant\n12. Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2\n13. Recent exposure to COVID-19 infection within 14 days or recent onset of symptoms within 14 days that may be related to COVID-19 infection",{"count":165,"type":21},18,[167],"PHASE1","This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg\u002Fkg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg\u002Fkg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg\u002Fkg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.",[170,27],"Mild Cognitive Impairment","2026-01-05",{"date":173,"type":38},"2026-01-07",{"date":175,"type":38},"2023-03-13",{"date":78,"type":21},{"name":178,"class":45},"NYU Langone Health",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":81},"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":188,"type":21},12,[58],"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",[61,62,27,63,192,193],"Apathy","Apathy in Dementia",[195,136,196,197,198,199,200,201],"apathy","Alzheimer's disease","methylphenidate","rTMS","iTBS","repetitive transcranial magnetic stimulation","intermittent theta burst stimulation","2025-12-11",{"date":204,"type":38},"2025-12-12",{"date":206,"type":21},"2026-01",{"date":208,"type":21},"2027-10-01",{"name":80,"class":45},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100610030","clinical-trial-protocol-alzheimers-dementia-underlying-encephalopathy-100610030","NCT07222280","Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy","Inclusion Criteria:\n\n* Ages 60 to 90 years old\n* No prior diagnosis of dementia\n* Currently hospitalized with cognitive diagnosis, including but no limited to; delirium, encephalopathy, etc. thought to be secondary to a toxic\u002Fmetabolic state\n\nExclusion Criteria:\n\n* Age under 60 years\n* Prior diagnosis of dementing illness or other organic etiology to cognitive impairment","90 Years",{"count":218,"type":21},30,[24],"The goal of this clinical trial is to determine if utilizing the Quest AD-Detect blood test, while patient's are hospitalized for a cognitive diagnosis (such as delirium or encephalopathy), will result in an earlier diagnosis of underlying Alzheimer's disease.\n\n* Will this blood test have the ability to distinguish between Alzheimer's disease and other causes of cognitive impairment in the inpatient setting?\n* Neurology Clinic will complete a 6-month post-hospitalization follow up with patients who have had the Quest AD-Detect Alzheimer's Disease blood test completed while they were inpatient to discuss the risk assessment portfolio",[27,63,222,223,224],"Delirium Confusional State","Encephalopathy","Cognitive Abnormality","2025-10-27",{"date":227,"type":38},"2025-10-29",{"date":229,"type":38},"2025-06-10",{"date":231,"type":21},"2026-03-31",{"name":233,"class":45},"Covenant Health, US",6,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":242,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100604661","therapeutic-efficacy-of-monoclonal-antibody-drugs-for-alzheimers-disease-based-on-pet-research-100604661","NCT07152418","Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research","A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research","Inclusion Criteria:\n\n* Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. \\[Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology\\]\n* Male or Female\n* Between 50 and 85 years old (inclusive)\n* Not currently participating in any other clinical trial or research study\n* Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form\n* Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion\n\nExclusion Criteria:\n\n* Any contraindication to MRI\n* History of seizure within the past 6 months or refractory epilepsy.\n* Unstable or severe psychiatric illness within the past 6 months.\n* History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \\\u003C50,000\u002FμL or INR \\>1.5).\n* Uncontrolled diabetes mellitus or hypertension.\n* History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.\n* Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).\n* Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.\n* Breastfeeding individuals or women of childbearing potential not using highly effective contraception.\n* History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.",{"count":121,"type":21},"Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ\u002Ftau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.",[96,27,245],"Mild Cognitive Impairment (MCI)",[63,100,247,248],"Tau PET","Aβ PET","2025-08-26",{"date":251,"type":38},"2025-09-03",{"date":253,"type":21},"2025-09-01",{"date":255,"type":21},"2028-09-01",{"name":111,"class":45},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":265,"sex":17,"minAge":266,"maxAge":4,"enrollmentInfo":267,"targetDuration":269,"studyType":93,"phases":4,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":81},"100603752","environmental-pollutants-and-neurological-disorders-100603752","NCT07140601","Environmental Pollutants and Neurological Disorders","Environmental Pollutants and Neurological Disorders: Clinical and Mechanistic Study","CLEAN","Inclusion Criteria:\n\n* 18 years of age or older;\n* Able to give informed consent to participate in the research.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Pregnant or breastfeeding woman.",true,"18 Years",{"count":268,"type":21},500,"24 Months","Environmental pollutants have emerged as a major global health concern, with growing evidence linking exposure to both traditional contaminants such as heavy metals (lead, mercury, cadmium, arsenic) and novel pollutants-including micro- and nanoplastics, per- and polyfluoroalkyl substances (PFAS), antibiotics, and endocrine-disrupting chemicals-to adverse neurological outcomes. These pollutants can cross or disrupt the blood-brain barrier, accumulate in neural tissue, and trigger oxidative stress, inflammation, epigenetic modifications, and metabolic reprogramming.\n\nBrain tumours and cerebrovascular diseases represent two major categories of neurosurgical disorders with high morbidity and mortality. However, their interaction with environmental pollutant exposure remains poorly understood. Recent studies suggest that pollutant-induced molecular alterations, such as aberrant DNA methylation, lipid metabolism disruption, and neurovascular endothelial dysfunction, may contribute to tumour initiation, malignant progression, aneurysm formation, and stroke occurrence.\n\nGiven the increasing human exposure to these pollutants and the lack of large-scale clinical data, it is urgent to establish a systematic investigation in neurosurgical patients. This study aims to profile pollutant exposure (heavy metals, PFAS, microplastics, and other novel contaminants) using multi-biospecimen analysis (blood, urine, hair, tumour and peri-tumour tissues), and to explore their mechanistic links to the pathogenesis of brain tumours and cerebrovascular diseases. The findings are expected to provide new evidence for understanding environment-brain interactions and to identify potential biomarkers for disease risk stratification and prevention.",[272,273,27],"Cerebrovascular Disorders","Brain Tumours",[275,276,277,278,279],"Environmental Pollutants","Exposomics","Pathogenic Mechanisms","Neurological Disorders","Neurosurgical Patients","2025-08-22",{"date":282,"type":38},"2025-08-24",{"date":284,"type":38},"2025-08-01",{"date":286,"type":21},"2027-08-01",{"name":288,"class":45},"Beijing Tiantan Hospital",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":305,"leadSponsor":307,"locationsCount":4},"100598079","phase-2-clinical-study-to-evaluate-the-efficacy-and-safety-of-huperzine-a-controlled-release-tablets-in-patients-with-mild-to-moderate-dementia-of-the-alzheimers-type-100598079","NCT07066826","Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type","A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate in the study and signs the informed consent form jointly with a legally authorized representative (LAR). If the subject is unable to sign due to cognitive impairment or other reasons, the signature field for the subject may be left blank, with the reason specified and signed by the LAR. In such cases, the LAR must sign the informed consent form on behalf of the subject.\n2. Aged ≥50 and ≤85 years, male or female.\n3. Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia according to the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) guidelines.\n4. Has experienced memory impairment for at least 12 months, with a chronic and progressively worsening course.\n5. Has received ≥5 years of formal education and is able to complete the protocol-specified cognitive assessments.\n6. Diagnosed with Stage 4 or 5 (mild to moderate dementia) according to the Revised Clinical Staging of Alzheimer's Disease (2024) (i.e., Clinical Dementia Rating \\[CDR\\] global score of 1 or 2).\n7. Total score on the Mini-Mental State Examination (MMSE) is between 11 and 26 inclusive.\n8. Has undergone a cranial MRI scan showing a Medial Temporal Atrophy (MTA) visual rating scale grade ≥1. If the subject has completed an eligible MRI at this or another tertiary hospital within 6 months prior to screening, and it meets the protocol requirements, re-scanning is not required.\n9. Capable of undergoing positron emission tomography (PET) imaging.\n10. Hachinski Ischemic Score (HIS) ≤ 4.\n11. Hamilton Depression Rating Scale (HAMD-17) score of ≤10.\n12. No obvious focal neurological signs on physical examination, except those attributable to peripheral injury.\n13. Has a stable and reliable caregiver, or is in frequent contact with a caregiver (at least 4 days per week and ≥2 hours per day). The caregiver must accompany the subject to study visits, provide reliable information for scale assessments based on sufficient interaction and communication with the subject, and should remain the same throughout the study whenever possible.\n\nExclusion Criteria:\n\n1. Subjects who are allergic to the active ingredient or excipients of huperzine A controlled-release tablets or donepezil, or those with lactose intolerance.\n2. Cognitive impairment or dementia not caused by Alzheimer's disease (AD), including:\n\n(1) Other neurodegenerative diseases (e.g., dementia with Lewy bodies, frontotemporal degeneration, Huntington's disease, Parkinson's disease); (2) Non-degenerative neurological conditions causing cognitive impairment or dementia (e.g., vascular cognitive impairment or dementia, hydrocephalus, encephalitis, hypoxic brain injury, traumatic brain injury); (3) Non-neurological systemic diseases causing cognitive impairment or dementia (e.g., endocrine disorders such as hypothyroidism, hepatic insufficiency, hepatic encephalopathy, dialysis encephalopathy, neurosyphilis, HIV); (4) Cognitive impairment or dementia caused by vitamin deficiencies (e.g., folate or vitamin B12 deficiency).\n\n3.Subjects diagnosed, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with psychiatric disorders within the past 12 months that are unstable or may interfere with study assessments, including but not limited to schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, delirium, or substance (including alcohol) use disorders with dependence.\n\n4.Subjects with significant focal brain lesions on MRI, including but not limited to any of the following (if a qualifying head MRI was performed within 6 months prior to screening and meets protocol requirements, repeat imaging is not required):\n\n1. Presence of lesions indicating large-area cerebral infarction;\n2. Infarcts in critical brain regions (e.g., thalamus, hippocampus, entorhinal cortex, parahippocampal gyrus, angular gyrus, cortical or subcortical gray matter nuclei);\n3. More than two infarcts with a diameter \\>2 cm, and deemed by the investigator to impact cognitive assessments;\n4. Multiple lacunar infarcts, deemed by the investigator to impact cognitive assessments;\n5. Severe white matter lesions;\n6. Intracerebral hemorrhage deemed likely to affect cognitive assessments by the investigator;\n7. Hydrocephalus.\n\n5.Subjects with uncontrolled seizures (and\u002For epilepsy syndromes), or those with cognitive impairment caused or potentially caused by recurrent seizures or antiepileptic drug use.\n\n6.Subjects who experienced acute cardiovascular or cerebrovascular events within 3 months prior to screening (e.g., unstable angina, second- or third-degree atrioventricular block or other serious arrhythmias, myocardial infarction, decompensated congestive heart failure of NYHA class III or IV, transient ischemic attack, or ischemic stroke).\n\n7.Subjects with uncontrolled hypertension or hypotension at screening (defined as systolic blood pressure ≥160 mmHg or \\\u003C90 mmHg, or diastolic blood pressure ≥100 mmHg or \\\u003C60 mmHg after pharmacologic or non-pharmacologic treatment); subjects with slight deviations beyond this range but deemed clinically insignificant by the investigator may be included.\n\n8.Subjects with serious active gastrointestinal disorders (e.g., severe gastroesophageal reflux, gastrointestinal bleeding, or peptic ulcers) within 3 months prior to screening, or who have undergone any surgical procedures that may affect drug absorption (e.g., total gastrectomy, total small bowel resection).\n\n9.Subjects with other uncontrolled clinical conditions (e.g., malignancies, severe infectious diseases, respiratory diseases).\n\n10.Subjects with sinus bradycardia at screening (resting heart rate \\\u003C60 bpm) that is deemed clinically significant by the investigator.\n\n11.Subjects with corrected QT interval using Fridericia's formula (QTcF) \\>450 ms in males or \\>470 ms in females at screening or baseline.\n\n12.Subjects with renal dysfunction (serum creatinine \\[Scr\\] \\>1.5× the upper limit of normal \\[ULN\\] per the study center laboratory) or hepatic dysfunction (ALT or AST \\>2× ULN).\n\n13.Subjects with thyroid function abnormalities at screening that are deemed clinically significant and unsuitable for study participation by the investigator.\n\n14.Subjects who test positive for syphilis antibodies or HIV antibodies. 15.Subjects who received donanemab within 2 months prior to screening; lecanemab within 5 weeks prior to screening; or any other medication for the treatment of AD or cognitive enhancement within 4 weeks prior to screening, including but not limited to cholinesterase inhibitors, NMDA receptor antagonists, and other nootropic agents.\n\n16.Subjects who participated in any drug clinical trial (excluding vitamins and minerals) within 1 month prior to screening or 7 half-lives of the study drug (whichever is longer), or who are currently participating in another clinical trial.\n\n17.Subjects who are unable to complete the required scale assessments due to uncorrectable vision or hearing impairments.\n\n18.Subjects who are unable to complete study-required assessments due to personal limitations, such as contraindications to MRI scanning.\n\n19.Subjects of childbearing potential (male or female) who are unwilling to use effective contraception from the start of the study until 6 months after the end of the study, and\u002For female subjects of childbearing potential who are unwilling or unable to undergo pregnancy testing.\n\n20.Pregnant or breastfeeding women. 21.Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the study.",{"count":297,"type":21},720,[58,123],"This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.",[27],"2025-07-11",{"date":303,"type":38},"2025-07-15",{"date":284,"type":21},{"date":306,"type":21},"2028-08-15",{"name":308,"class":309},"Wanbangde Pharmaceutical Group Co., LTD","INDUSTRY"]