[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656258":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":30,"overallOfficials":11,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":11,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":11,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Eisai Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter",null,"Baseline up to Follow-up, up to 10 years",[14,16],{"measure":15,"description":11,"timeFrame":12},"Incidence and exposure-adjusted incidence rate of seizure, anaphylaxis, central nervous system (CNS) ischemic event, and Death",{"measure":17,"description":18,"timeFrame":12},"Incidence Rate of AESIs","Incidence and exposure-adjusted incidence rate of AESIs will be assessed by count (n) and proportion (%) of APOE genotype, baseline MRI findings consistent with a high risk for CAA, prior AD treatments, and antithrombotic therapy.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":20,"timePerspective":21,"maskingInfo":11},"COHORT","PROSPECTIVE","The study will use data from the ALZ-NET registry, which is expected to include about 20,000 patients being evaluated for- or treated with- new FDA-approved AD therapies. About 6,700 (33%) of these patients are expected to be treated with LEQEMBI.","Participants prescribed lecanemab-irmb by a physician participating in the ALZ-NET registry.",[25],{"label":26,"type":11,"description":27,"interventionNames":28},"All Participants","Participants will be prescribed with lecanemab-irmb by physicians participating in the ALZ-NET registry based on the approved United States Prescribing Information (USPI).",[29],"Other: No Intervention",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"OTHER","No Intervention","This is a non-interventional study.",[26],[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Eisai Medical Information","CONTACT","+1-888-274-2378","esi_medinfo@eisai.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":11},"Eisai Trial Site #1","RECRUITING","Nutley","New Jersey","07110","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.15987,40.82232,{"lat":55,"lon":54},{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656258","a-postmarketing-study-of-lecanemab-for-the-treatment-of-participants-with-alzheimers-disease-100656258",false,"NCT07821658","A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease","A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diagnostics [ALZ-NET] Registry Data)","Inclusion Criteria:\n\n* Enrolled in ALZ-NET\n* Either currently receiving or previously received lecanemab-irmb.\n\nExclusion Criteria:\n\n-None","ALL",{"count":68,"type":69},6700,"ESTIMATED","OBSERVATIONAL","The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 cm in participants treated with lecanemab-irmb.\n\nThe secondary purpose of this study is to:\n\nEvaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.\n\nAssess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET.\n\nAssess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.",[73],"Alzheimer's Disease",[73,75,76,77],"Early Alzheimer's Disease","LEQEMBI","ARIA","2026-09-09",{"date":80,"type":81},"2026-09-16","ACTUAL",{"date":83,"type":81},"2025-05-23",{"date":85,"type":69},"2035-01-15",{"name":5,"class":6},1]