RecruitingNCT06810960

A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease

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


Sponsor

Eisai Korea Inc.

Enrollment

3,000 participants

Start Date

Feb 24, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This post-marketing study is collecting real-world data on how lecanemab (brand name Leqembi) works in South Korean patients with Alzheimer's disease. Lecanemab is a newly approved drug that targets amyloid plaques in the brain to slow cognitive decline in early Alzheimer's. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with Alzheimer's disease and your doctor has determined you are suitable for lecanemab treatment in South Korea - You have a study partner (such as a family member or caregiver) who can provide separate consent - You are willing to share your medical information for research purposes **You may NOT be eligible if...** - You are currently enrolled in another interventional clinical trial - You have medical contraindications to lecanemab as per the approved South Korean prescribing information Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention

This is a non-interventional study.


Locations(1)

Eisai Trial Site #1

Nutley, New Jersey, United States

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NCT06810960


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