Postmarketing safety monitoring of LEQEMBI in people with Alzheimer's disease in South Korea
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
This follow-up will see if LEQEMBI is safe for people with Alzheimer's in South Korea by tracking brain imaging findings and bleeding-related side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Eisai Inc. Industry-sponsored |
| Locations | 1 site (Nutley, New Jersey) |
| Trial ID | NCT06810960 on ClinicalTrials.gov |
What this trial studies
This observational postmarketing program follows South Korean patients with Alzheimer's disease who have already been prescribed LEQEMBI to monitor real-world safety. It collects routine clinical and imaging reports of amyloid-related imaging abnormalities (ARIA), including ARIA-E and ARIA-H, symptomatic ARIA, and intracerebral hemorrhage greater than 1 cm. Eligible participants must have been enrolled in JOY-ALZ before the decision to treat with LEQEMBI, have the clinical decision to treat already made, and provide consent to share medical information with Eisai Korea; patients in interventional trials are excluded. No investigational procedures are applied and safety data are derived from medical records and routine clinical imaging.
Who should consider this trial
Good fit: Ideal candidates are people with Alzheimer's disease in South Korea who were enrolled in JOY-ALZ before deciding to start LEQEMBI and who agree to share their medical records with Eisai Korea.
Not a fit: Patients not receiving LEQEMBI, those currently enrolled in interventional clinical trials, or those who do not consent to data sharing are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this will provide better real-world safety information about ARIA and serious bleeding risks with LEQEMBI in a Korean patient population, helping clinicians manage treatment.
How similar studies have performed: Prior clinical trials and early real-world reports of lecanemab/LEQEMBI have documented ARIA rates and management approaches, but comprehensive postmarketing safety data specifically in Korean populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nutley, New Jersey
- Eisai Trial Site #1 — Nutley, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Eisai Korea Inc. Medical department Serena SoYoun Kwon
- Email: s-kwon@eisaikorea.com
- Phone: +82-2-3451-5533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.