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

Description

The primary purpose of this study is to evaluate safety of lecanemab 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 participants treated with lecanemab.

Conditions

Alzheimer's Disease

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Study Overview

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Study Details

Study overview

The primary purpose of this study is to evaluate safety of lecanemab 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 participants treated with lecanemab.

A 6-Year Postmarketing Safety and Clinical Outcome Study of Lecanemab 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

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

Condition
Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Nutley

Eisai Trial Site #1, Nutley, New Jersey, United States, 07110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years or older at consent
  • * Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea
  • * Has an identified study partner who provides separate written informed consent
  • * Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
  • * Currently participating in an interventional clinical study
  • * Has contraindications for lecanemab according to the approved prescribing information in South Korea

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eisai Korea Inc.,

Study Record Dates

2029-12-31