A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab

Recruiting

• Conditions: Alzheimer's Disease

• Registration Number: NCT06322667
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-14
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• All participants who are treated with lecanemab in routine clinical practice

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)	Up to 156 weeks
Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA	Up to 156 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Infusion Related Reaction	Up to 156 weeks

Trial Locations

Locations (3)

Eisai trial site 2; 🇯🇵 Hiroshima, Japan

Eisai trial site 3; 🇯🇵 Kyoto, Japan

Eisai trial site 1; 🇯🇵 Tokyo, Japan