221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Public ClinicalTrials.gov record NCT02477800. 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 Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) \[ADAS-Cog 13\], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) \[ADCS-ADL-MCI\].
Study identification
- NCT ID
- NCT02477800
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,653 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 85 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
- Aug 12, 2015
- Primary completion
- Aug 7, 2019
- Completion
- Aug 7, 2019
- Last update posted
- Sep 1, 2021
2015 – 2019
United States locations
- U.S. sites
- 59
- U.S. states
- 25
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| Senior Clinical Trials, Inc. | Laguna Hills | California | 92653 | — |
| Torrance Clinical Research Institute, Inc. | Lomita | California | 90717 | — |
| University of California - Los Angeles | Los Angeles | California | 90095 | — |
| UCSF - Memory and Aging Center | San Francisco | California | 94158 | — |
| California Neuroscience Research Medical Group Inc. | Sherman Oaks | California | 91403 | — |
| Southern California Research LLC | Simi Valley | California | 93065 | — |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20057 | — |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | — |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Miami Jewish Health Systems | Miami | Florida | 33137 | — |
| Compass Research Main | Orlando | Florida | 32806 | — |
| Palm Beach Neurological Center | Palm Beach Gardens | Florida | 33410 | — |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | — |
| USF Health Byrd Institute | Tampa | Florida | 33616 | — |
| Meridien Research | Tampa | Florida | 33634 | — |
| Compass Research Main | The Villages | Florida | 32162 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Cleveland Clinic Florida - Weston | Weston | Florida | 33331 | — |
| Alexian Brothers Neurosciences Institute | Elk Grove Village | Illinois | 60007 | — |
| 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, Inc. | Kansas City | Kansas | 66160 | — |
| Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. | Wichita | Kansas | 67214 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Brigham & Women's Hosp End/Dbt | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | — |
| Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts | 02360 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University | St Louis | Missouri | 63131 | — |
| Las Vegas Medical research | Las Vegas | Nevada | 89113 | — |
| Advanced Memory Research Institute of NJ, PC | Toms River | New Jersey | 08755 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| New York University Medical Center PRIME | New York | New York | 10016 | — |
| University of Rochester | Rochester | New York | 14620 | — |
| ANI Neurology, PLLC d/b/a Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | — |
| Raleigh Neurology Associates, P.A. | Raleigh | North Carolina | 27607-6010 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Northeastern Pennsylvania Memory and Alzheimer's Center | Plains | Pennsylvania | 18705 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02915 | — |
| Butler Hospital | Providence | Rhode Island | 02906 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Neurology Clinic, PC | Cordova | Tennessee | 38108 | — |
| University of Tennessee Medical Center. Knoxville | Knoxville | Tennessee | 37920 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | — |
| Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53266 | — |
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 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02477800, 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 Sep 1, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02477800 live on ClinicalTrials.gov.