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Recruiting NCT06322667

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

— Observational Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: Alzheimer's Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other No Intervention
    This is a non-interventional study.

Primary outcome measures

  • 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]
  • Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA [Time frame: Up to 156 weeks]
Secondary outcome measures (1)
  • Number of Participants With Infusion Related Reaction [Time frame: Up to 156 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 3 centers
  • Eisai trial site 2 — Hiroshima
  • Eisai trial site 3 — Kyoto
  • Eisai trial site 1 — Tokyo

Identifiers

NCT: NCT06322667 · BAN2401-J081-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗