Actively Recruiting
A 6-Year Postmarketing Safety and Clinical Outcome Study of LEQEMBI in Alzheimer's Disease Using Real-World Data From the South Korean JOY-ALZ Registry
Led by Eisai Korea Inc. · Updated on 2026-04-21
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of LEQEMBI in patients with Alzheimer's disease in a real-world clinical setting. The study focuses on tracking specific events related to amyloid-related imaging abnormalities (ARIA), including ARIA-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage larger than 1 centimeter. The aim is to gather safety data over a long period while patients receive LEQEMBI treatment. This is an observational, non-interventional study where patients with Alzheimer's disease are treated with LEQEMBI according to the approved prescribing information by their physician during routine clinical practice. Data will be collected from the South Korean JOY-ALZ registry, which tracks patients receiving this treatment. There is no placebo or comparator group, and treatment decisions are made prior to enrollment. Participants will be followed for up to 6 years, during which researchers will monitor and record the incidence and rates of adverse events of special interest, including ARIA-related events and other adverse drug reactions. They will also observe serious adverse events and reactions. The study collects real-world data to better understand the safety profile of LEQEMBI over time in the South Korean population with Alzheimer's disease.
CONDITIONS
Brief Title
A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Currently participating in an interventional clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm registry enrollment and eligibility
Duration - Up to 6 years
Participants who undergo routine care with LEQEMBI in clinical practice are observed through data collection from the JOY-ALZ registry to assess safety and clinical outcomes.
Periodic visits as part of routine clinical care with data collected from the registry
Trial Site Locations
Total: 1 location
1
Eisai Trial Site #1
Nutley, New Jersey, United States, 07110
Actively Recruiting
Research Team
E
Eisai Korea Inc. Medical department Serena SoYoun Kwon
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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