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NCT06322667 Clinical Trial

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

Alzheimer's Disease Clinical Trial

Official title:
A Multicenter, Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimer's Disease and Treated With Lecanemab

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06322667
Other study ID # BAN2401-J081-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 22, 2023
Est. completion date December 31, 2027

Study information
Verified date March 2024
Source Eisai Inc.
Contact Eisai Inquiry Service.
Email eisai-chiken_hotline@hhc.eisai.co.jp
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All participants who are treated with lecanemab in routine clinical practice Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations
Country Name City State
Japan Eisai trial site 2 Hiroshima
Japan Eisai trial site 3 Kyoto
Japan Eisai trial site 1 Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA Up to 156 weeks
Secondary Number of Participants With Infusion Related Reaction Up to 156 weeks
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