A Post Authorization Registry Study of Participants Treated With LEQEMBI
About this study
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.
- Condition
- Alzheimers Disease
- Tested
- No Intervention
- Sponsor
- Eisai Limited
Who can join
- Age
- Not specified
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 2
- Study condition: Alzheimers Disease
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Where
17 sites, 17 recruiting
Toronto Memory Program
Toronto, Ontario, Canada
University of Calgary - Hotchkiss Brain Institute
Calgary, Alberta, Canada
University of Alberta, Geriatric Division
Edmonton, Alberta, Canada
Gatineau Memory Clinic
Gatineau, Quebec, Canada
MOCA
Greenfield Park, Quebec, Canada
Kingston HHC (Queen University)
Kingston, Ontario, Canada
and 11 more sites on ClinicalTrials.gov
Contact
-
Eisai Medical Information
+1-888-274-2378 esi_medinfo@eisai.com
Potential match only. Final eligibility is determined by the study team.