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NCT06322667

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

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
Eisai Co., Ltd.·ClinicalTrials.gov·otherRecruiting
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Study focus
Disease/Condition
Alzheimer's Disease
Drug/Device/Intervention
No Intervention
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Eisai Co., Ltd.
Funder
Eisai Inc.
Location
Hiroshima,Kyoto,Tokyo, Japan
Timeline & enrollment
Phase
N/A
Start date
Dec 22, 2023
End date
Dec 31, 2027
Enrollment
5000 participants
Primary outcome

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),Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA

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.

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06322667
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06322667 through Pure Global AI's free database. This phase not specified trial is sponsored by Eisai Co., Ltd. and is currently Recruiting. The study focuses on Alzheimer's Disease. Target enrollment is 5000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.