A Post Authorization Registry Study of Participants Treated With LEQEMBI
Post Authorization Registry Study of Patients Treated With LEQEMBI
1 other identifier
observational
400
1 country
11
Brief Summary
To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \[CAA\]). The secondary purpose of this study is, To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm. To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality). To describe drug utilization of LEQEMBI and to assess the 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 P75+ for all trials
Started Jul 2026
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2036
August 13, 2026
July 1, 2026
9.7 years
July 20, 2026
August 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Known AEs
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH \>1 cm in diameter in participants treated with LEQEMBI.
Up to 3 years
Secondary Outcomes (5)
Time to Progression to the Next Stage of Alzheimer's Disease
Up to 3 years
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Up to 3 years
Drug Utilization of LEQEMBI
Up to 3 years
Duration of Treatment
Up to 3 years
Effectiveness of Risk Minimization Measures
Up to 3 years
Study Arms (1)
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada
Interventions
Eligibility Criteria
The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.
You may qualify if:
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Limitedlead
Study Sites (11)
University of British Columbia - CARD
Vancouver, British Columbia, Canada
UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
Victoria, British Columbia, Canada
Parkwood Hospital - London
London, Ontario, Canada
Trillium Hospital
Mississauga, Ontario, Canada
Bruyère Institute
Ottawa, Ontario, Canada
Kawartha Center
Peterborough, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
McGill University, Douglas Mental Health
Montreal, Quebec, Canada
CHU de Québec-Université Laval Research Center
Québec, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
August 13, 2026
Study Start
July 31, 2026
Primary Completion (Estimated)
April 1, 2036
Study Completion (Estimated)
April 1, 2036
Last Updated
August 13, 2026
Record last verified: 2026-07
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/.