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

Eisai Korea Inc.3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Alzheimer's Disease

Interventions

No InterventionOTHER

This is a non-interventional study.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Eisai Trial Site #1

Nutley, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 6 years

Secondary Outcomes

Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs)

Time frame: Up to 6 years

Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs

Time frame: Up to 6 years

Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information

Time frame: Up to 6 years

Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information

Time frame: Up to 6 years

Incidence of ARIA-Related Events by Baseline Characteristics

Baseline characteristics include APOE4 genotype status, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease treatments, and antithrombotic therapy.

Time frame: Up to 6 years

Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics

Baseline characteristics include APOE4 genotype status, baseline MRI findings, prior Alzheimer's disease treatments, and antithrombotic therapy.

Central Contacts

Eisai Korea Inc. Medical department Serena SoYoun Kwon

CONTACT

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

Data from ClinicalTrials.gov

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