Postmarketing safety monitoring of LEQEMBI in people with Alzheimer's disease in South Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.