ClinicalTrials.gov record
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT03887455
Public ClinicalTrials.gov record NCT03887455. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03887455
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,906 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2019 (Actual)
- Primary completion
- Dec 31, 2026 (Estimated)
- Completion
- Dec 31, 2026 (Estimated)
- Last update posted
- Oct 6, 2026
2019 – 2026
United States locations
- U.S. sites
- 112
- U.S. states
- 30
- U.S. cities
- 85
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Alzheimer's Institute- Clinical Trials Department | Phoenix | Arizona | 85006 | — |
| Banner Sun Health Research | Sun City | Arizona | 85351 | — |
| Neurological Associates of Tucson dba Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| University of California - Los Angeles | Los Angeles | California | 90045 | — |
| Pacific Neuroscience Medical Group | Oxnard | California | 93030 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Pacific Research Network, Inc | San Diego | California | 92103 | — |
| Sharp Neurocognitive Research Center | San Diego | California | 92123 | — |
| UCSF Memory and Aging Center | San Francisco | California | 94158 | — |
| Apex Research Institute | Santa Ana | California | 92705 | — |
| St Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| ImmunoE Research Center | Centennial | Colorado | 80112 | — |
| Mile High Research Center | Denver | Colorado | 80218 | — |
| Associated Neurologists of Southern Connecticut | Fairfield | Connecticut | 06824 | — |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | — |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20057 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | — |
| Linfritz Research Institute, Inc. | Coral Gables | Florida | 33134 | — |
| Brain Matters Research | Delray Beach | Florida | 33445 | — |
| Neuropsychiatric Research Center of Southwest FL | Fort Myers | Florida | 33912 | — |
| Infinity Clinical Research | Hollywood | Florida | 33024 | — |
| Clincloud, LLC | Maitland | Florida | 32751 | — |
| BioMed Research Institute | Miami | Florida | 33126 | — |
| Finlay Medical Research | Miami | Florida | 33126 | — |
| CCM Clinical Research Group | Miami | Florida | 33133 | — |
| Advance Medical Research Center | Miami | Florida | 33135 | — |
| Advanced Clinical Research Network | Miami | Florida | 33135 | — |
| Gonzalez MD & Aswad MD Health Services | Miami | Florida | 33135 | — |
| Vitae Research Center | Miami | Florida | 33135 | — |
| Miami Jewish Health Systems | Miami | Florida | 33137 | — |
| Allied Biomedical Research (Clinical Trial) | Miami | Florida | 33155 | — |
| Pharmax Research of South Florida, Inc | Miami | Florida | 33175 | — |
| IMIC, Inc. | Miami | Florida | 33176 | — |
| Visionary Investigators Network | Miami | Florida | 33176 | — |
| Visionary Investigators Network | Miami | Florida | 33180 | — |
| Galiz Research | Miami Springs | Florida | 33016 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Synexus Clinical Research US, Inc. | Orlando | Florida | 32806 | — |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | — |
| Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida | 33410 | — |
| Quantum Laboratories Inc. | Pompano Beach | Florida | 33064 | — |
| Neurostudies, Inc. | Port Charlotte | Florida | 33952 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Alzheimer's Research and Treatment Center | Stuart | Florida | 34996 | — |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | — |
| USF Suncoast Gerontology Center | Tampa | Florida | 33613 | — |
| Charter Research | The Villages | Florida | 32162 | — |
| Synexus Clinical Research | The Villages | Florida | 32162 | — |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | — |
| Premiere Research Institute, West Palm | West Palm Beach | Florida | 33407 | — |
| Emory University Cognitive Neurology Clinic & ADRC | Atlanta | Georgia | 30329 | — |
| Columbus Memory Center | Columbus | Georgia | 31909 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| NeuroStudies.net, LLC | Decatur | Georgia | 30030 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66205 | — |
| KU Wichita Center for Clinical Research | Wichita | Kansas | 67214 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40504 | — |
| McLean Hospital | Belmont | Massachusetts | 02478 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | — |
| Boston Center for Memory | Newton | Massachusetts | 02459 | — |
| Donald S. Marks, MD. P.C. | Plymouth | Massachusetts | 02360 | — |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | — |
| Washington University | St Louis | Missouri | 63108 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Advanced Memory Research Institute of NJ, PC | Toms River | New Jersey | 08755 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Neurological Associates of Albany, PC | Albany | New York | 12208 | — |
| New York University Medical Center PRIME | New York | New York | 10016 | — |
| Neurological Institute of New York | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14620 | — |
| ANI Neurology, PLLC d/b/a Alzheimer's Memory Center | Matthews | North Carolina | 28105 | — |
| Raleigh Neurology Associates, P.A. - Research Department | Raleigh | North Carolina | 27607 | — |
| PMG Research of Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| NeuroScience Research Center LLC | Canton | Ohio | 44718 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Columbs Neuroscience, LLC | Columbus | Ohio | 43020 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Summit Research Network (OR) Inc. | Portland | Oregon | 97210 | — |
| Neural Net Research, LLC | Portland | Oregon | 97225 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Keystone Clinical Studies, LLC | Plymouth Meeting | Pennsylvania | 19462 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Butler Hospital - Memory and Aging Program | Providence | Rhode Island | 02906 | — |
| Ralph H. Johnson VA Health Care System | North Charleston | South Carolina | 29401 | — |
| Coastal Neurology, P.A. | Port Royal | South Carolina | 29935 | — |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | — |
| Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company | Knoxville | Tennessee | 37920 | — |
| Senior Adult Specialty Research | Austin | Texas | 78757 | — |
| Texas Neurology, PA | Dallas | Texas | 75206 | — |
| Kerwin Research Center | Dallas | Texas | 75231 | — |
| Baylor College of Medicine AD and Memory Disorders Center | Houston | Texas | 77030 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| DBA The Memory Clinic | Bennington | Vermont | 05201 | — |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | — |
| Kingfisher Cooperative LLC | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 135 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03887455, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03887455 live on ClinicalTrials.gov.