A Post Authorization Registry Study of Participants Treated With LEQEMBI (NCT07762092)
Post Authorization Registry Study of Patients Treated With LEQEMBI
🩺 Plain-English Summary (8th-Grade Level)
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: Review the eligibility criteria below.
Location: University of British Columbia - CARD — Vancouver, British Columbia
🧪 Interventions in This Study
- No Intervention (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- University of British Columbia - CARD — Vancouver, British Columbia
- UBC Victoria - Neil and Susan Manning Cognitive Health Initiative — Victoria, British Columbia
- Parkwood Hospital - London — London, Ontario
- Trillium Hospital — Mississauga, Ontario
- Bruyère Institute — Ottawa, Ontario
- Kawartha Center — Peterborough, Ontario
- Sunnybrook Hospital — Toronto, Ontario
- Toronto Memory Program — Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario
- McGill University, Douglas Mental Health — Montreal, Quebec
- CHU de Québec-Université Laval Research Center — Québec, Quebec
📞 Contact the Study Coordinator
Phone: (888) 274-2378
Email: esi_medinfo@eisai.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.