A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease

NCT07864623 | Not Yet Recruiting FDA Drug

• 1 other identifier: BAN2401-A001-507
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants from BAN2401-G000-301 (Study 301) Core study on change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.

Conditions

Alzheimers Disease

Keywords

Early Alzheimer's disease; LEQEMBI

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the CDR-SB

  Baseline, 18 months

Secondary Outcomes (1)

• Time to Progression to the Next Stage of Alzheimer's Disease as Assessed by Global CDR Score

  Baseline, 18 months

Study Arms (1)

Participants Treated With Lecanemab

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Participants Treated With Lecanemab

Eligibility Criteria

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

Study Population

Participants with early Alzheimer's Disease treated with lecanemab will be observed retrospectively.

You may qualify if:

• Participant (or legally authorized representative) has provided written informed consent to participate in the local site registry
• Mild cognitive impairment (MCI) due to AD or mild AD dementia, according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
• Global CDR at baseline of 0.5 or 1
• APOE4 heterozygous or noncarrier
• Have had a baseline CDR-SB (before initiation of LEQEMBI treatment)
• Completed 18 months of LEQEMBI treatment, with an 18-month CDR-SB assessment

You may not qualify if:

• Use of any other anti-amyloid treatment prior to and during the 18-month LEQEMBI treatment period
• Conditions highlighted under "Contraindications" section in the Canadian Product Monograph

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

Location

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 Eisai Inc.

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 8, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: October 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)