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 range19 Years

SexALL

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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

What they're measuring

Incidence of Adverse Events of Special Interest (AESIs)

Timeframe: Up to 6 years

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

+82-2-3451-5533 s-kwon@eisaikorea.com

View on ClinicalTrials.gov More Alzheimer's Disease trials