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

A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (Early Alzheimer's Disease), Who Are Apolipoprotein Epsilon 4 (ApoE Epsilon 4) Noncarriers or Heterozygous Carriers With Confirmed Amyloid Pathology

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how well LEQEMBI works over 18 months in people with early Alzheimer's disease who have zero or one copy of the APOE4 gene variant. It compares changes in memory, thinking, and daily tasks with people from an earlier study who received a placebo, a treatment with no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative gave written consent to join the study site's patient registry.
  • You have mild thinking or memory problems due to Alzheimer's disease, or mild Alzheimer's dementia, based on standard medical rules.
  • Your starting Clinical Dementia Rating (CDR), a score of dementia symptoms, was 0.5 or 1.
  • You have zero or one copy of the APOE4 gene variant.
  • You had a CDR-SB assessment, which scores memory, thinking, and daily tasks, before starting LEQEMBI.
  • You completed 18 months of LEQEMBI treatment and had a CDR-SB assessment at 18 months.

Who can't join

  • You used any other anti-amyloid treatment before or during the 18 months of LEQEMBI treatment. These treatments target a protein called amyloid.
  • You have a condition listed in the Canadian LEQEMBI drug guide as a reason not to use the drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

NJ