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LEQEMBI Safety in South Korean Alzheimer's Patients

This study is looking at the real-world safety of LEQEMBI in people with Alzheimer's disease in South Korea. It's an observational study, meaning participants will already be taking LEQEMBI as part of their regular care. The study aims to understand how often certain side effects, called amyloid-related imaging abnormalities (ARIA), occur. These include ARIA-edema (swelling in the brain) and ARIA-hemosiderin deposition (small bleeds in the brain), as well as larger brain bleeds. To join, you must have already decided with your doctor to take LEQEMBI and agree to share your medical information. The study plans to include 3000 participants.

Study design
This is an observational study, meaning there's no intervention from the researchers; you'll already be taking LEQEMBI as part of your regular care. It aims to enroll 3000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06810960

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

Recruiting
Not specifiedAges 19+Observational
Eisai Korea Inc.
~3,000 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:No Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events of Special Interest (AESIs)
Measured over Up to 6 years
+1 more outcome measured

Conditions

Alzheimer's Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Eisai Korea Inc. Medical department Serena SoYoun Kwon
[email protected]
+82-2-3451-5533
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Currently participating in an interventional clinical study

What this trial measures

  • Incidence of Adverse Events of Special Interest (AESIs)Up to 6 years

    AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.

  • Exposure-adjusted Incidence Rate of AESIsUp to 6 years

    AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.