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Post Authorization Registry Study of Patients Treated With LEQEMBI

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

Locations
Other Locations
Canada
University of Calgary - Hotchkiss Brain Institute
NOT_YET_RECRUITING
Calgary
University of Alberta, Geriatric Division
NOT_YET_RECRUITING
Edmonton
Clinique Neuro-Outaouais
NOT_YET_RECRUITING
Gatineau
MOCA
NOT_YET_RECRUITING
Greenfield Park
Kingston HHC (Queen University)
NOT_YET_RECRUITING
Kingston
Parkwood Hospital - London
NOT_YET_RECRUITING
London
Trillium Hospital
NOT_YET_RECRUITING
Mississauga
IUGM
NOT_YET_RECRUITING
Montreal
McGill University, Douglas Mental Health
NOT_YET_RECRUITING
Montreal
Bruyère Institute
NOT_YET_RECRUITING
Ottawa
Kawartha Center
RECRUITING
Peterborough
CHU de Québec-Université Laval Research Center
NOT_YET_RECRUITING
Québec
Sunnybrook Hospital
NOT_YET_RECRUITING
Toronto
Toronto Memory Program
RECRUITING
Toronto
Toronto Western Hospital
NOT_YET_RECRUITING
Toronto
University of British Columbia - CARD
NOT_YET_RECRUITING
Vancouver
UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
NOT_YET_RECRUITING
Victoria
Contact Information
Primary
Eisai Medical Information
esi_medinfo@eisai.com
+1-888-274-2378
Time Frame
Start Date: 2026-07-30
Estimated Completion Date: 2036-04-01
Participants
Target number of participants: 400
Treatments
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada
Sponsors
Leads: Eisai Limited

This content was sourced from clinicaltrials.gov

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