Health TrialsbyHealthPanel

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

ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorEisai Korea Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Currently participating in an interventional clinical study

Trial population

Patients with alzheimer's disease prescribed LEQEMBI based on the approved prescribing information in South Korea and clinical judgement.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is a non-interventional study.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: LEQEMBI1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Korea Inc.

Lead sponsor

Source ClinicalTrials.gov
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