An observational study in Alzheimer's Disease, sponsored by Eisai Inc.. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Eisai Inc. · Observational
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 6,700 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants prescribed lecanemab-irmb by a physician participating in the ALZ-NET registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-None
Participants will be prescribed with lecanemab-irmb by physicians participating in the ALZ-NET registry based on the approved United States Prescribing Information (USPI).
Other: No Intervention
This is a non-interventional study.
Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter
Time frame: Baseline up to Follow-up, up to 10 years
Incidence and exposure-adjusted incidence rate of seizure, anaphylaxis, central nervous system (CNS) ischemic event, and Death
Time frame: Baseline up to Follow-up, up to 10 years
Incidence Rate of AESIs
Incidence and exposure-adjusted incidence rate of AESIs will be assessed by count (n) and proportion (%) of APOE genotype, baseline MRI findings consistent with a high risk for CAA, prior AD treatments, and antithrombotic therapy.
Time frame: Baseline up to Follow-up, up to 10 years
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
No publications or documents are linked to this record.
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