[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mci-ad-early-stage-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mci-ad-early-stage-alzheimers-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100640973","phase-4-evaluating-the-efficacy-and-safety-of-lecanemab-in-alzheimers-disease-through-multi-omics-approachs-100640973",false,"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.","ALL","50 Years","90 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Alzheimer s Disease","Alzheimer Dementia (AD)","MCI-AD, Early Stage Alzheimer's Disease","RECRUITING","2026-05-17",{"date":33,"type":34},"2026-05-22","ACTUAL",{"date":36,"type":34},"2026-01-01",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"First Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"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.","85 Years",{"count":51,"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.",[56,57,29],"Alzheimer Disease (AD)","Alzheimer Dementia",[59,60,61],"Alzheimer's Disease","lecanemab","different doses","NOT_YET_RECRUITING","2026-03-26",{"date":65,"type":34},"2026-04-01",{"date":67,"type":21},"2026-04-30",{"date":69,"type":21},"2028-01-31",{"name":71,"class":41},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":16,"minAge":80,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"100581460","phase-2-efficacy-and-safety-of-dimethyl-fumarate-among-patients-with-mild-cognitive-impairment-and-dementia-due-to-alzheimers-disease-100581460","NCT06850597","Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease","Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease","Inclusion Criteria:\n\n1. Men and women aged 55-90 years.\n2. Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate Alzheimer's dementia (MMSE \\>16) diagnosed based on NIA-AA criteria.\n3. MMSE score from 17 to 30 points.\n4. CDR score from 0.5 to 2.\n5. The patient signs an informed, voluntary consent to participate in the study.\n6. The patient has a close person\u002Fde facto guardian who agrees to help the patient during participation in the study.\n7. At least 6 years of education.\n8. In the case of anti-Alzheimer's drugs, the use of cholinesterase inhibitors is permitted provided that they are included at least 3 months before entering the study and used at a stable dose for at least 60 days before entering the study. In the case of memantine, its use is permitted provided that it is included at least 4 months before entering the study and used at a stable dose for at least 3 months before entering the study.\n\nExclusion Criteria:\n\n1. Lack of informed voluntary consent to participate in the study.\n2. Patients who cannot read or write.\n3. Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).\n4. Participation in another clinical trial, currently or within 3 months prior to the screening visit.\n5. Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.\n6. Chronic kidney disease with GFR below \\\u003C 60 ml\u002Fmin\u002Fm2\n7. Abnormal liver parameters: ALAT exceeding \\> 2 times the upper limit of normal\n8. Leukopenia (\\\u003C4000\u002Fmm3), granulocytopenia (\\\u003C1500\u002Fmm3) or lymphopenia (\\\u003C1000\u002Fmm3) regardless of the cause.\n9. Severe agitation.\n10. Mental retardation.\n11. Delirium diagnosed according to DSM-5 criteria.\n12. Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke).\n13. Presence of hemorrhagic foci in magnetic resonance imaging with a diameter of ≥ 2 cm3, more than three (3) ischemic stroke foci with a diameter of ≥ 1.5 cm3 or a single ischemic foci with a diameter of ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normal pressure hydrocephalus, final decision at the discretion of the investigator.\n14. Severe or uncontrolled somatic disease that could affect the course of the study (e.g. neoplastic, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant hypertension).\n15. Use of benzodiazepines or barbiturates within 1 week prior to screening.\n16. Pharmacological immunosuppression.\n17. Patients with bipolar disorder or psychotic disorders or any other psychiatric condition (current or past) that the Investigator believes interferes with the study.\n18. Alcoholism or drug addiction as defined by DSM-5 within the past 5 years (dependent for more than 1 year and or in remission for less than 3 years).\n19. Patients with any medical condition that, in the Investigator's judgment, is an exclusion criterion.\n20. Thyroid hormone therapy initiated, discontinued, or modified within 3 months prior to screening visit.\n21. Menopausal hormone replacement therapy initiated, discontinued, or modified within 3 months prior to screening visit.\n22. Use of prohibited drugs in the study: Antineoplastic drugs (no studies). Immunosuppressive drugs (no studies). Corticosteroids (impact on project results). Live attenuated vaccines (no studies). Inactivated vaccines may be used. Benzodiazepines (impact on assessed endpoints). Other ethyl esters used orally or topically.",true,"55 Years",{"count":82,"type":21},30,[84],"PHASE2","The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.",[87,29,59],"MCI","2025-02-24",{"date":90,"type":34},"2025-02-27",{"date":92,"type":34},"2024-10-28",{"date":94,"type":21},"2027-12-31",{"name":96,"class":41},"Medical University of Lodz"]