AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
Public ClinicalTrials.gov record NCT04468659. 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
AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.
Study identification
- NCT ID
- NCT04468659
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,400 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 55 Years to 80 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
- Jul 14, 2020 (Actual)
- Primary completion
- Dec 21, 2028 (Estimated)
- Completion
- Jan 16, 2031 (Estimated)
- Last update posted
- Jun 4, 2026
2020 – 2031
United States locations
- U.S. sites
- 72
- U.S. states
- 31
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35233 | — |
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | — |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| UCI MIND | Irvine | California | 92697-4285 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | — |
| University of California, San Francisco | San Francisco | California | 94158 | — |
| University of California, Davis | Walnut Creek | California | 94598 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | — |
| Howard University | Washington D.C. | District of Columbia | 20060 | — |
| Advanced Clinical Research Network, Corp | Coral Gables | Florida | 33134-1613 | — |
| Brain Matters Research | Delray Beach | Florida | 33445 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| K2 Medical Research - The Villages | Lady Lake | Florida | 32159 | — |
| K2 Medical Research, Llc | Maitland | Florida | 32751 | — |
| Gonzalez MD & Aswad MD Health Sciences | Miami | Florida | 33125 | — |
| Wien Center for Clinical Research | Miami Beach | Florida | 33140 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Synexus Clinical Research - Orlando | Orlando | Florida | 32806 | — |
| University of South Florida - Health Byrd Alzheimer Institute | Tampa | Florida | 33613 | — |
| Synexus Clinical Research - The Villages | The Villages | Florida | 32162 | — |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | — |
| Charter Research | Winter Park | Florida | 31792 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| Columbus Memory Center | Columbus | Georgia | 31909 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Kansas | Fairway | Kansas | 66205 | — |
| University of Kentucky | Lexington | Kentucky | 40504 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Boston University | Boston | Massachusetts | 02118 | — |
| Brigham and Woman's Hospital Center for Alzheimer Research and Treatment | Boston | Massachusetts | 21155 | — |
| Donald S.Marks, M.D.,P.C. | Plymouth | Massachusetts | 02360 | — |
| University of Michigan | Ann Arbor | Michigan | 48105 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Washington University, St. Louis | St Louis | Missouri | 63108 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | — |
| Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | 08755 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14620 | — |
| Duke Health Center | Durham | North Carolina | 27705 | — |
| AMC Research | Matthews | North Carolina | 28105 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Case Western Reserve University/University Hospitals | Beachwood | Ohio | 44122 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Central States Research, LLC | Tulsa | Oklahoma | 74136 | — |
| Summit Research Network, Oregon | Portland | Oregon | 97210 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | — |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Butler Hospital Memory and Aging Program | Providence | Rhode Island | 02906 | — |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 20403 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| University of Texas, Southwestern MC at Dallas | Dallas | Texas | 75390 | — |
| University of North Texas Health Sciences Center | Fort Worth | Texas | 76107 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Neurological Institute | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | — |
| University of Washington Memory and Brain Wellness Center | Seattle | Washington | 98104 | — |
| SIBCR | Seattle | Washington | 98108 | — |
| University of Wisconsin, Madison | Madison | Wisconsin | 53792 | — |
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 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04468659, 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 Jun 4, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04468659 live on ClinicalTrials.gov.