A Post Authorization Registry Study of Participants Treated With LEQEMBI

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.

🚫 You may not be able to join if…

• None

Where this trial is running

• 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

Who to contact

Eisai Medical Information · +1-888-274-2378 · esi_medinfo@eisai.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07762092.