A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
Part of paid clinical trials in Nutley, New Jersey.
- Sponsor
- Eisai Korea Inc.
- Study ID
- NCT06810960
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- No Intervention — OTHERThis is a non-interventional study.
Study Details
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.
Key Dates
- Start date
- Feb 24, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 3,000 participants (estimated)
Arms
- Arm: LEQEMBIPatients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry.
Primary Outcome Measure
Incidence of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 6 years ]
Central Contacts
- Eisai Korea Inc. Medical department Serena SoYoun Kwon+82-2-3451-5533
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eisai Trial Site #1 | Nutley | New Jersey | 07110 | - |
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