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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06810960

Enrollment

3000

Registered

2025-02-06

Start date

2025-02-24

Completion date

2029-09-30

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, LEQEMBI, ARIA

Brief 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.

Interventions

OTHERNo Intervention

This is a non-interventional study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 AESIs	Up to 6 years	AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.

Secondary

Measure	Time frame	Description
Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs)	Up to 6 years	—
Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs	Up to 6 years	—
Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information	Up to 6 years	—
Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information	Up to 6 years	—
Incidence of ARIA-Related Events by Baseline Characteristics	Up to 6 years	Baseline characteristics include APOE4 genotype status, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease treatments, and antithrombotic therapy.
Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics	Up to 6 years	Baseline characteristics include APOE4 genotype status, baseline MRI findings, prior Alzheimer's disease treatments, and antithrombotic therapy.
Incidence of AEs by Baseline Characteristics	Up to 6 years	Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.
Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics	Up to 6 years	Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.

Countries

United States

Contacts

CONTACTEisai Korea Inc. Medical department Serena SoYoun Kwon

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026