๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-01

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (NCT03887455)

A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Eisai Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Banner Alzheimer's Institute- Clinical Trials Department โ€” Phoenix, Arizona

Age range: 50 Years to 90 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (247 Sites)

Showing the first 25 of 247 sites.

  • Banner Alzheimer's Institute- Clinical Trials Department โ€” Phoenix, Arizona
  • Banner Sun Health Research โ€” Sun City, Arizona
  • Neurological Associates of Tucson dba Center for Neurosciences โ€” Tucson, Arizona
  • Neurology Center of North Orange County โ€” Fullerton, California
  • Irvine Clinical Research โ€” Irvine, California
  • University of California - Los Angeles โ€” Los Angeles, California
  • Pacific Neuroscience Medical Group โ€” Oxnard, California
  • Stanford University Medical Center โ€” Palo Alto, California
  • Pacific Research Network, Inc โ€” San Diego, California
  • Sharp Mesa Vista Hospital โ€” San Diego, California
  • UCSF Memory and Aging Center โ€” San Francisco, California
  • Apex Research Institute โ€” Santa Ana, California
  • St Joseph Heritage Healthcare โ€” Santa Rosa, California
  • North Bay Neuroscience Research Institute โ€” Sebastopol, California
  • ImmunoE Research Center โ€” Centennial, Colorado
  • Mile High Research Center โ€” Denver, Colorado
  • Associated Neurologists of Southern Connecticut โ€” Fairfield, Connecticut
  • Institute for Neurodegenerative Disorders โ€” New Haven, Connecticut
  • Yale University School Of Medicine โ€” New Haven, Connecticut
  • Research Center for Clinical Studies, Inc. โ€” Norwalk, Connecticut
  • Georgetown University Hospital โ€” Washington D.C., District of Columbia
  • JEM Research Institute โ€” Atlantis, Florida
  • Bradenton Research Center, Inc. โ€” Bradenton, Florida
  • Advanced Clinical Research Network โ€” Coral Gables, Florida
  • Linfritz Research Institute, Inc. โ€” Coral Gables, Florida

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—