[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646788":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Lecanemab Treatment Group","EXPERIMENTAL","Participants in this arm will receive Lecanemab treatment according to the standard clinical protocol for Alzheimer's disease. Their plasma biomarkers will be monitored using the mesoporous gold electrode ECL system to evaluate therapeutic efficacy.",[13],"Drug: Lecanemab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Lecanemab","Participants will receive Lecanemab (10 mg\u002Fkg) via intravenous infusion every two weeks for a total of 18 months. The dosage and frequency follow the standard prescribing information for Alzheimer's disease treatment.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xuhua Xu","CONTACT","+8613705790560","fupinglangying@zju.edu.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"The First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Yiwu","Zhejiang","322000","China","CN",{"type":37,"coordinates":38},"Point",[39,40],120.07676,29.31506,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":44,"phoneExt":20,"email":26},"+86 13705790560",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100646788","phase-4-evaluation-system-for-lecanemab-efficacy-using-gold-electrode-ecl-to-monitor-alzheimers-biomarkers-100646788",false,"NCT07688460","Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers","Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers","ECL-Lecanemab","Inclusion Criteria:\n\n1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.\n2. Age between 50 and 90 years (inclusive).\n3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers).\n4. Mini-Mental State Examination (MMSE) score between 22 and 30.\n5. Clinical Dementia Rating (CDR) global score of 0.5 or 1.\n6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening.\n7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring.\n8. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).\n2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.\n3. Use of anticoagulants that cannot be safely interrupted.\n4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.\n5. Known hypersensitivity to Lecanemab or any excipients.\n6. Pregnant or breastfeeding women.\n7. Participation in another interventional clinical trial within the last 30 days.","ALL","50 Years","90 Years",{"count":59,"type":60},100,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","This study aims to evaluate the therapeutic efficacy of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma. By tracking changes in these biomarkers, the study seeks to determine how effectively Lecanemab treats the disease and to validate this new ECL-based monitoring system as a useful tool for clinical assessment.",[66],"Alzheimer Disease","2026-07-01",{"date":69,"type":70},"2026-07-07","ACTUAL",{"date":72,"type":60},"2026-07-10",{"date":74,"type":60},"2029-03-30",{"name":5,"class":6},1]