Observing the effects of lecanemab in early Alzheimer's disease patients
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
Run by Eisai Inc. · NCT06322667 · Data updated 2026-11-12
This study looks at how lecanemab affects early Alzheimer's patients and what happens to them if they experience certain side effects while on the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Drugs / interventions | lecanemab |
| Locations | 3 sites (Hiroshima and 2 other locations) |
| Status | Recruiting |
| Started | February 14, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT06322667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with early Alzheimer's disease who are currently receiving treatment with lecanemab.
✕Probably not a fit
Patients who are not being treated with lecanemab or those with advanced stages of Alzheimer's disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the characteristics of amyloid-related imaging abnormalities (ARIA) in patients with early Alzheimer's disease who are being treated with lecanemab. It will also assess the treatment continuation status, including whether patients continue or interrupt their treatment after experiencing ARIA. The study will gather data from routine clinical practice to better understand the real-world implications of lecanemab treatment. Participants will be monitored without any additional interventions.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of lecanemab for patients with early Alzheimer's disease.
How similar studies have gone: Other studies have shown success in monitoring ARIA in Alzheimer's treatments, making this approach relevant and potentially beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All participants who are treated with lecanemab in routine clinical practice Exclusion Criteria: * None
Where it's running
-
Eisai trial site 2
Hiroshima, Japan Recruiting -
Eisai trial site 3
Kyoto, Japan Recruiting -
Eisai trial site 1
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Eisai Inquiry Service.
- Email: eisai-chiken_hotline@hhc.eisai.co.jp
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.