Active — Not RecruitingPhase 3

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

United States, Australia, Canada1,906 participantsStarted 2019-03-27

Plain-language summary

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

In countries where lecanemab is authorized for use in APOE4 noncarriers and heterozygous carriers only, APOE4 homozygous carriers will not be eligible for participation in Extension Phase Part B. Any APOE4 homozygous carriers that are already participating in Extension Phase Part B in such countries will be discontinued from the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Core Study: Change from Baseline in the CDR-SB at 18 Months

Timeframe: Baseline, 18 months

Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase

Extension Phase: Change from Core Study Baseline in CDR-SB

Timeframe: Baseline up to Month 66

Extension Phase Part B: Number of Participants Exposed to Lecanemab

Timeframe: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)

Trial details

NCT IDNCT03887455

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-30

View on ClinicalTrials.gov More Early Alzheimer's Disease trials