A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease (NCT06810960) | Clinical Trial Compass
RecruitingNot Applicable
A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
United States3,000 participantsStarted 2025-02-24
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events of Special Interest (AESIs)
Timeframe: Up to 6 years
2
Exposure-adjusted Incidence Rate of AESIs
Timeframe: Up to 6 years
Trial details
NCT IDNCT06810960
SponsorEisai Korea Inc.
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2029-09-30
Contact for this trial
Eisai Korea Inc. Medical department Serena SoYoun Kwon