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)
| Registry | NCT07821658 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 6700 (Estimated) |
| Sponsor | Eisai Inc. (Industry) |
| Conditions | Alzheimer's Disease |
| Interventions | No Intervention (Other) |
| Dates | start 2025-05-23, primary completion 2035-01-15 (estimated), completion 2035-01-15 (estimated), first posted 2026-09-16, last updated 2026-09-16 |
| Locations | 1 site in United States |
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All trials for Alzheimer's Disease All trials of No Intervention
The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 cm in participants treated with lecanemab-irmb.
The secondary purpose of this study is to:
Evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.
Assess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET.
Assess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.
The study will use data from the ALZ-NET registry, which is expected to include about 20,000 patients being evaluated for- or treated with- new FDA-approved AD therapies. About 6,700 (33%) of these patients are expected to be treated with LEQEMBI.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| All Participants | Other: No Intervention | Participants will be prescribed with lecanemab-irmb by physicians participating in the ALZ-NET registry based on the approved United States Prescribing Information (USPI). |
Sex: All
Inclusion Criteria: * Enrolled in ALZ-NET * Either currently receiving or previously received lecanemab-irmb. Exclusion Criteria: -None
| Facility | City | Country | Status |
|---|---|---|---|
| Eisai Trial Site #1 | Nutley, New Jersey | United States | Recruiting |