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

January 22, 2026 updated by: Eisai Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Hiroshima, Japan
        • Recruiting
        • EISAI Trial Site 2
      • Kyoto, Japan
        • Recruiting
        • EISAI Trial Site 3
      • Tokyo, Japan
        • Recruiting
        • EISAI Trial Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants prescribed lecanemab by a physician in routine clinical practice.

Description

Inclusion Criteria:

  • All participants who are treated with lecanemab in routine clinical practice

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
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.
Other: No Intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA
Time Frame: Up to 156 weeks
Up to 156 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Infusion Related Reaction
Time Frame: Up to 156 weeks
Up to 156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAN2401-J081-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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