A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
Recruiting
- Conditions
- Alzheimer's Disease
- Interventions
- Other: No Intervention
- 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
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
- Arm && Interventions
Group Intervention Description All Participants No Intervention Participants prescribed lecanemab by a physician in routine clinical practice (post-marketing surveillance) will be observed prospectively for up to a maximum of 156 weeks or to the time of discontinuation, whichever occurs first.
- 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 1
🇯🇵Tokyo, Japan
Eisai trial site 2
🇯🇵Hiroshima, Japan
Eisai trial site 3
🇯🇵Kyoto, Japan