RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-24
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810960

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older at consent
  2. * 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
  3. * Has an identified study partner who provides separate written informed consent
  4. * Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
  1. * Currently participating in an interventional clinical study
  2. * Has contraindications for lecanemab according to the approved prescribing information in South Korea

Contacts and Locations

Study Contact

Medical department Serena SoYoun Kwon
CONTACT
+82-2-3451-5533
s-kwon@eisaikorea.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Eisai Korea Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease
  • Lecanemab
  • ARIA

Additional Relevant MeSH Terms

  • Alzheimer's Disease