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

NCT06322667 | Recruiting FDA Drug

• 1 other identifier: BAN2401-J081-401
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 3

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 (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.

Conditions

Alzheimer's Disease

Keywords

Early Alzheimer's Disease; Lecanemab; ARIA

Outcome Measures

Primary Outcomes (2)

• 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)

  Up to 156 weeks

• Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA

  Up to 156 weeks

Secondary Outcomes (1)

• Number of Participants With Infusion Related Reaction

  Up to 156 weeks

Study Arms (1)

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

Interventions

No Intervention OTHER

This is a non-interventional study.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants prescribed lecanemab by a physician in routine clinical practice.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (3)

Eisai trial site 2

Hiroshima, Japan

RECRUITING

Eisai trial site 3

Kyoto, Japan

RECRUITING

Eisai trial site 1

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eisai Inquiry Service.

CONTACT

eisai-chiken_hotline@hhc.eisai.co.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)