No Intervention: This is a non-interventional study.
Study summary
The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Enrolled in JOY-ALZ before the decision to treat with LEQEMBI
* The clinical decision to treat with LEQEMBI has already been made
* Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
Exclusion Criteria:
* Currently participating in an interventional clinical study
Primary outcome measure(s)
Incidence of Adverse Events of Special Interest (AESIs) — Up to 6 years AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Exposure-adjusted Incidence Rate of AESIs — Up to 6 years AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Trial sites (1)
Facility
City
Region
Status
Eisai Trial Site #1
Nutley
New Jersey
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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