A 6-Year Postmarketing Safety and Clinical Outcome Study of LEQEMBI® 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
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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.
Locations
United States
New Jersey
Eisai Trial Site #1
RECRUITING
Nutley
Contact Information
Primary
Eisai Korea Inc. Medical department Serena SoYoun Kwon
s-kwon@eisaikorea.com
+82-2-3451-5533
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 3000
Treatments
LEQEMBI
Patients 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.
Related Therapeutic Areas
Sponsors
Leads: Eisai Korea Inc.