A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease

NCT07821658 | Recruiting FDA Drug

• 1 other identifier: BAN2401-A001-501
• Study Type: observational
• Target: 6,700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Early Alzheimer's Disease; LEQEMBI; ARIA

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline up to Follow-up, up to 10 years

Secondary Outcomes (2)

• Incidence and exposure-adjusted incidence rate of seizure, anaphylaxis, central nervous system (CNS) ischemic event, and Death

  Baseline up to Follow-up, up to 10 years

• Incidence Rate of AESIs

  Baseline up to Follow-up, up to 10 years

Study Arms (1)

All Participants

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

Interventions

No Intervention OTHER

This is a non-interventional study.

All Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants prescribed lecanemab-irmb by a physician participating in the ALZ-NET registry.

You may qualify if:

• Enrolled in ALZ-NET
• Either currently receiving or previously received lecanemab-irmb.

You may not qualify if:

• None

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378; esi_medinfo@eisai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 16, 2026
• Study Start: May 23, 2025
• Primary Completion (Estimated): January 15, 2035
• Study Completion (Estimated): January 15, 2035
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)