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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06322667

Enrollment

5000

Registered

2024-03-21

Start date

2024-02-14

Completion date

2027-12-31

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Early Alzheimer's Disease, Lecanemab, ARIA

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.

Interventions

OTHERNo Intervention

This is a non-interventional study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

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)	Up to 156 weeks
Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA	Up to 156 weeks

Secondary

Measure	Time frame
Number of Participants With Infusion Related Reaction	Up to 156 weeks

Countries

Japan

Contacts

CONTACTEisai Inquiry Service.

eisai-chiken_hotline@hhc.eisai.co.jp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026