Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322667
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-03-14
Brief Title:
A Post Marketing Study in Participants With Early Alzheimers Disease Treated With Lecanemab
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimers Disease and Treated With Lecanemab
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg continuation interruption after the onset of ARIA in routine clinical practice in participants treated with lecanemab
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None