RecruitingNCT07762092

A Post Authorization Registry Study of Participants Treated With LEQEMBI

Post Authorization Registry Study of Patients Treated With LEQEMBI


Sponsor

Eisai Limited

Enrollment

400 participants

Start Date

Jul 30, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria1

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

Exclusion Criteria1

  • None

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Interventions

OTHERNo Intervention

No intervention.


Locations(17)

University of Calgary - Hotchkiss Brain Institute

Calgary, Alberta, Canada

University of Alberta, Geriatric Division

Edmonton, Alberta, Canada

University of British Columbia - CARD

Vancouver, British Columbia, Canada

UBC Victoria - Neil and Susan Manning Cognitive Health Initiative

Victoria, British Columbia, Canada

Kingston HHC (Queen University)

Kingston, Ontario, 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

Gatineau Memory Clinic

Gatineau, Quebec, Canada

MOCA

Greenfield Park, Quebec, Canada

IUGM

Montreal, Quebec, Canada

McGill University, Douglas Mental Health

Montreal, Quebec, Canada

CHU de Québec-Université Laval Research Center

Québec, Quebec, Canada

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NCT07762092


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