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A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab - Trial NCT06322667

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.

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NCT06322667
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Trial Details
ClinicalTrials.gov โ€ข NCT06322667
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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

Study Focus

Alzheimer's Disease

No Intervention

Observational

other

Sponsor & Location

Eisai Co., Ltd.

Eisai Inc.

Hiroshima,Kyoto,Tokyo, Japan

Timeline & Enrollment

N/A

Dec 22, 2023

Dec 31, 2027

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 disease
Alzheimer disease, unspecified
Other Alzheimer disease
Dementia in Alzheimer disease
Dementia in Alzheimer disease, unspecified

Data Source

ClinicalTrials.gov

NCT06322667

Non-Device Trial