A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease
A 6-Year Postmarketing Safety and Clinical Outcome Study of Lecanemab in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry
Eisai Korea Inc.
3,000 participants
Feb 24, 2025
OBSERVATIONAL
Conditions
Summary
The primary purpose of this study is to evaluate safety of lecanemab 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 participants treated with lecanemab.
Eligibility
Inclusion Criteria4
- years or older at consent
- Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea
- Has an identified study partner who provides separate written informed consent
- Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
Exclusion Criteria2
- Currently participating in an interventional clinical study
- Has contraindications for lecanemab according to the approved prescribing information in South Korea
Interventions
This is a non-interventional study.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06810960