Lecanemab-irmb in Real-World Use for Alzheimer’s Disease
Official title: A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diagnostics [ALZ-NET] Registry Data)
Run by Eisai Inc. · NCT07821658 · Data updated 2026-11-12
This study tests the safety of lecanemab-irmb in people with Alzheimer’s disease by looking at real-world brain-image changes and related events.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 6700 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Drugs / interventions | lecanemab |
| Locations | 1 site (Nutley, New Jersey) |
| Status | Recruiting |
| Started | May 23, 2025 |
| Main results expected | January 15, 2035 |
| Study ends | January 15, 2035 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07821658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals enrolled in ALZ-NET who are currently receiving or have previously received lecanemab-irmb.
✕Probably not a fit
Patients not treated with lecanemab-irmb or not enrolled in ALZ-NET may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, postmarketing effort using ALZ-NET data to monitor safety signals associated with lecanemab-irmb in patients diagnosed with Alzheimer's disease. The study tracks events such as ARIA (edema and hemosiderin deposition), symptomatic ARIA, intracerebral hemorrhage, seizures, anaphylaxis, CNS ischemic events, and death in a real-world setting. It will also examine how safety outcomes vary with factors like APOE genotype, MRI signs of cerebral amyloid angiopathy risk, prior Alzheimer’s treatments, and antithrombotic use. No new treatment is administered as part of the study; data are drawn from existing clinical practice. The project leverages the ALZ-NET registry, which includes a large cohort of patients evaluated for or treated with new FDA-approved AD therapies.
Why it matters
Potential benefit: If successful, the study could clarify the real-world safety profile of lecanemab-irmb to better guide clinicians and patients.
How similar studies have gone: Prior studies and postmarketing surveillance have documented ARIA and related events with anti-amyloid therapies; this study extends real-world safety monitoring to a large registry.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in ALZ-NET * Either currently receiving or previously received lecanemab-irmb. Exclusion Criteria: -None
Where it's running
-
Eisai Trial Site #1
Nutley, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Eisai Medical Information
- Email: esi_medinfo@eisai.com
- Phone: +1-888-274-2378
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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.