RecruitingRecruiting
A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
NCT06322667 · Eisai Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* All participants who are treated with lecanemab in routine clinical practice
Exclusion Criteria:
* None
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-02-14
Estimated completion: 2027-12-31
Last updated: 2026-01-23
Interventions
Other: No Intervention
Primary outcomes
- • 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)
Sponsor
Eisai Co., Ltd. · industry
Contacts & investigators
ContactEisai Inquiry Service. · contact · eisai-chiken_hotline@hhc.eisai.co.jp
All locations (3)
Eisai trial site 2Recruiting
Hiroshima, Japan
Eisai trial site 3Recruiting
Kyoto, Japan
Eisai trial site 1Recruiting
Tokyo, Japan