Observing the effects of lecanemab in early Alzheimer's disease patients
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
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eisai Inc. Industry-sponsored |
| Drugs / interventions | lecanemab |
| Locations | 3 sites (Hiroshima and 2 other locations) |
| Trial ID | NCT06322667 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with early Alzheimer's disease who are currently receiving treatment with lecanemab.
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.
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 performed: Other studies have shown success in monitoring ARIA in Alzheimer's treatments, making this approach relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All participants who are treated with lecanemab in routine clinical practice Exclusion Criteria: * None
Where this trial is running
Hiroshima and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.