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

NCT ID: NCT06322667

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-14

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai trial site 2

Hiroshima, , Japan

Site Status RECRUITING

Eisai trial site 3

Kyoto, , Japan

Site Status RECRUITING

Eisai trial site 1

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Eisai Inquiry Service.

Role: CONTACT

Other Identifiers

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BAN2401-J081-401

Identifier Type: -

Identifier Source: org_study_id

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