[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659744":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":35,"armGroups":36,"interventions":42,"overallOfficials":11,"centralContacts":48,"locations":54,"responsibleParty":148,"collaborators":11,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":11,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":11,"maxAge":11,"enrollmentInfo":158,"targetDuration":11,"studyType":161,"phases":11,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":169,"whyStopped":11,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},{"fullName":5,"class":6},"Eisai Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Known Adverse Events (AEs)",null,"Up to 2 years",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice","Incidence and severity of serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.",{"measure":18,"description":19,"timeFrame":12},"Time to Progression to the Next Stage of Alzheimer's Disease","The stages of disease are assessed by the clinician using tools that they use in routine clinical practice, and are mild cognitive impairment (MCI) due to AD, mild AD, moderate AD, or severe AD.",{"measure":21,"description":22,"timeFrame":12},"Drug Utilization of LEQEMBI","Drug utilization will be assessed by baseline demographics, apolipoprotein E4 variant (APOE4) genotype, AD diagnosis, and baseline magnetic resonance imaging (MRI) findings, baseline antithrombotic use.",{"measure":24,"description":25,"timeFrame":12},"Duration of Treatment","Drug Utilization of LEQEMBI will be assessed by Duration of Treatment",{"measure":27,"description":28,"timeFrame":12},"Incidence of Serious ARIA and ICH","Incidence of serious ARIA and ICH \\>1 cm in diameter will be assessed",{"measure":30,"description":31,"timeFrame":12},"Effectiveness of Risk Minimization Measures","Effectiveness of Risk Minimization Measures will be assessed by the proportion of participants using antithrombotic medications during treatment, demonstrating compliance with the MRI monitoring schedule and with dose suspension or discontinuation of LEQEMBI for ARIA-E, ARIA-H, or ICH \\>1 cm in diameter, and physician compliance with the package insert and providing educational materials to participants.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":33,"timePerspective":34,"maskingInfo":11},"COHORT","PROSPECTIVE","The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan and are enrolled into the PASS Registry either prior to initiation or after beginning of therapy.",[37],{"label":38,"type":11,"description":39,"interventionNames":40},"Participants Treated With LEQEMBI","Patients with Alzheimer's Disease treated with LEQEMBI in routine clinical practice.",[41],"Other: No Intervention",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"OTHER","No Intervention","This is a non-interventional study.",[38],[49],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Eisai Medical Information","CONTACT","+1-888-274-2378","esi_medinfo@eisai.com",[55,67,76,82,88,94,100,109,118,127,133,139],{"facility":56,"status":11,"city":57,"state":11,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":11},"Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","833","Taiwan","TW",{"type":62,"coordinates":63},"Point",[64,65],120.31333,22.61626,{"lat":65,"lon":64},{"facility":68,"status":11,"city":69,"state":11,"zip":70,"country":59,"countryCode":60,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"Far Eastern Memorial Hospital","New Taipei City","220",{"type":62,"coordinates":72},[73,74],121.45703,25.06199,{"lat":74,"lon":73},{"facility":77,"status":11,"city":69,"state":11,"zip":78,"country":59,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":81,"contacts":11},"Cardinal Tien Hospital","231",{"type":62,"coordinates":80},[73,74],{"lat":74,"lon":73},{"facility":83,"status":11,"city":69,"state":11,"zip":84,"country":59,"countryCode":60,"cosmosGeoPoint":85,"geoPoint":87,"contacts":11},"Taipei Medical University Shuang Ho Hospital","235",{"type":62,"coordinates":86},[73,74],{"lat":74,"lon":73},{"facility":89,"status":11,"city":69,"state":11,"zip":90,"country":59,"countryCode":60,"cosmosGeoPoint":91,"geoPoint":93,"contacts":11},"New Taipei Municipal TuCheng Hospital","236",{"type":62,"coordinates":92},[73,74],{"lat":74,"lon":73},{"facility":95,"status":11,"city":69,"state":11,"zip":96,"country":59,"countryCode":60,"cosmosGeoPoint":97,"geoPoint":99,"contacts":11},"En Chu Kong Hospital","237",{"type":62,"coordinates":98},[73,74],{"lat":74,"lon":73},{"facility":101,"status":11,"city":102,"state":11,"zip":103,"country":59,"countryCode":60,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"Chung Shan Medical University Hospital","Taichung","402",{"type":62,"coordinates":105},[106,107],120.6839,24.1469,{"lat":107,"lon":106},{"facility":110,"status":11,"city":111,"state":11,"zip":112,"country":59,"countryCode":60,"cosmosGeoPoint":113,"geoPoint":117,"contacts":11},"National Cheng Kung University Hospital","Tainan","704",{"type":62,"coordinates":114},[115,116],120.21333,22.99083,{"lat":116,"lon":115},{"facility":119,"status":11,"city":120,"state":11,"zip":121,"country":59,"countryCode":60,"cosmosGeoPoint":122,"geoPoint":126,"contacts":11},"National Taiwan University Hospital","Taipei","100",{"type":62,"coordinates":123},[124,125],121.52639,25.05306,{"lat":125,"lon":124},{"facility":128,"status":11,"city":120,"state":11,"zip":129,"country":59,"countryCode":60,"cosmosGeoPoint":130,"geoPoint":132,"contacts":11},"Mackay Memorial Hospital-Taipei branch","104",{"type":62,"coordinates":131},[124,125],{"lat":125,"lon":124},{"facility":134,"status":11,"city":120,"state":11,"zip":135,"country":59,"countryCode":60,"cosmosGeoPoint":136,"geoPoint":138,"contacts":11},"Taipei Veterans General Hospital","112",{"type":62,"coordinates":137},[124,125],{"lat":125,"lon":124},{"facility":140,"status":11,"city":141,"state":11,"zip":142,"country":59,"countryCode":60,"cosmosGeoPoint":143,"geoPoint":147,"contacts":11},"Chang Gung Memorial Hospital, Linkou","Taoyuan","333",{"type":62,"coordinates":144},[145,146],121.29696,24.99368,{"lat":146,"lon":145},{"type":149,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659744","an-observational-study-of-leqembi-in-routine-clinical-practice-in-taiwan-100659744",false,"NCT07869264","An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan","An Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice in Taiwan","Inclusion Criteria:\n\n* Participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan.\n* Participants who have been prescribed LEQEMBI and who consent to enroll in the program.\n\nExclusion Criteria:\n\n* None","ALL",{"count":159,"type":160},100,"ESTIMATED","OBSERVATIONAL","The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema\u002Feffusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by apolipoprotein E4 variant \\[APOE4\\] genotype, concomitant antithrombotic therapy, and comorbid cerebral amyloid angiopathy \\[CAA\\]), in participants treated with LEQEMBI in routine clinical practice in Taiwan.\n\nTo describe previously unknown adverse events related to long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.\n\nTo describe progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice.\n\nTo describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.",[164],"Alzheimer's Disease",[164,166,167,168],"Early Alzheimer's Disease","LEQEMBI","ARIA","NOT_YET_RECRUITING","2026-10-06",{"date":172,"type":173},"2026-10-09","ACTUAL",{"date":175,"type":160},"2026-10-29",{"date":177,"type":160},"2030-09-30",{"name":179,"class":6},"Eisai Taiwan Inc.",12]