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A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
NCT03887455 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lecanemab IV
- DRUG Lecanemab SC
Study Locations (20)
California
- Neurology Center of North Orange County — Fullerton
- Irvine Clinical Research — Irvine
- University of California - Los Angeles — Los Angeles
- Pacific Neuroscience Medical Group — Oxnard
- Stanford University Medical Center — Palo Alto
- Pacific Research Network, Inc — San Diego
- Sharp Mesa Vista Hospital — San Diego
- UCSF Memory and Aging Center — San Francisco
- Apex Research Institute — Santa Ana
- St Joseph Heritage Healthcare — Santa Rosa
- North Bay Neuroscience Research Institute — Sebastopol
Connecticut
- Associated Neurologists of Southern Connecticut — Fairfield
- Institute for Neurodegenerative Disorders — New Haven
- Yale University School Of Medicine — New Haven
- Research Center for Clinical Studies, Inc. — Norwalk
Arizona
- Banner Alzheimer's Institute- Clinical Trials Department — Phoenix
- Banner Sun Health Research — Sun City
- Neurological Associates of Tucson dba Center for Neurosciences — Tucson
Colorado
- ImmunoE Research Center — Centennial
- Mile High Research Center — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,906 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03887455
The ClinicalTrials.gov registry entry for NCT03887455 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,906 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03887455 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Connecticut, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03887455 about?
NCT03887455 is a clinical study titled "A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease". 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...
What is the current status of trial NCT03887455?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,906 participants. The study started on 2019-03-27. Estimated completion is 2029-06-30.
What conditions does trial NCT03887455 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03887455?
The interventions under investigation include: Placebo (DRUG), Lecanemab IV (DRUG), Lecanemab SC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03887455?
This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03887455 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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