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NCT Number: NCT06810960

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame: Up to 6 years

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

  2. Exposure-adjusted Incidence Rate of AESIs

    Time frame: Up to 6 years

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

Secondary outcomes

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

  5. Incidence of ARIA-Related Events by Baseline Characteristics

    Time frame: Up to 6 years

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

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

    Time frame: Up to 6 years

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

  7. Incidence of AEs by Baseline Characteristics

    Time frame: Up to 6 years

    Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.

  8. Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics

    Time frame: Up to 6 years

    Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Korea Inc. Medical department Serena SoYoun Kwon

CONTACT

[email protected]

+82-2-3451-5533

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 6, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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