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
1 other identifier
observational
100
1 country
12
Brief Summary
The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (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. To 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. To describe progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice. To describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2026
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedStudy Start
First participant enrolled
October 29, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2030
October 9, 2026
September 1, 2026
3.9 years
October 6, 2026
October 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Known Adverse Events (AEs)
Up to 2 years
Secondary Outcomes (6)
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Up to 2 years
Time to Progression to the Next Stage of Alzheimer's Disease
Up to 2 years
Drug Utilization of LEQEMBI
Up to 2 years
Duration of Treatment
Up to 2 years
Incidence of Serious ARIA and ICH
Up to 2 years
- +1 more secondary outcomes
Study Arms (1)
Participants Treated With LEQEMBI
Patients with Alzheimer's Disease treated with LEQEMBI in routine clinical practice.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan.
- Participants who have been prescribed LEQEMBI and who consent to enroll in the program.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Cardinal Tien Hospital
New Taipei City, 231, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, 236, Taiwan
En Chu Kong Hospital
New Taipei City, 237, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, 104, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2026
First Posted
October 9, 2026
Study Start (Estimated)
October 29, 2026
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
October 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.