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

NCT06810960 | Recruiting FDA Drug

• 1 other identifier: BAN2401-M082-503
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; LEQEMBI; ARIA

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events of Special Interest (AESIs)

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

  Up to 6 years

• Exposure-adjusted Incidence Rate of AESIs

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

  Up to 6 years

Secondary Outcomes (8)

• 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

Study Arms (1)

LEQEMBI

Patients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

LEQEMBI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with alzheimer's disease prescribed LEQEMBI based on the approved prescribing information in South Korea and clinical judgement.

You may qualify if:

• 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.

You may not qualify if:

• Currently participating in an interventional clinical study

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (1)

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eisai Korea Inc. Medical department Serena SoYoun Kwon

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)