A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
Interventions
- Other No Intervention
This is a non-interventional study.
Primary outcome measures
- Incidence of Adverse Events of Special Interest (AESIs) [Time frame: Up to 6 years]
- Exposure-adjusted Incidence Rate of AESIs [Time frame: Up to 6 years]
Secondary outcome measures (8)
- 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 [Time frame: Up to 6 years]
- Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics [Time frame: Up to 6 years]
- Incidence of AEs by Baseline Characteristics [Time frame: Up to 6 years]
- Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics [Time frame: Up to 6 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Eisai Trial Site #1 — Nutley
Identifiers
NCT: NCT06810960 · BAN2401-M082-503