ClinicalTrials.gov record
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
ClinicalTrials.gov ID: NCT04437511
Public ClinicalTrials.gov record NCT04437511. 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
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.
Study identification
- NCT ID
- NCT04437511
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,736 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 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
- Jun 19, 2020 (Actual)
- Primary completion
- Apr 14, 2023 (Actual)
- Completion
- Nov 2028 (Estimated)
- Last update posted
- Aug 26, 2026
2020 – 2028
United States locations
- U.S. sites
- 185
- U.S. states
- 33
- U.S. cities
- 149
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gilbert Neurology | Gilbert | Arizona | 85297 | — |
| Xenoscience | Phoenix | Arizona | 85004 | — |
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | — |
| Perseverance Research Center | Scottsdale | Arizona | 85254 | — |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| Banner Alzheimer's Institute Tucson | Tucson | Arizona | 85718 | — |
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Health Initiatives Research | Fayetteville | Arkansas | 72703 | — |
| North County Neurology Associates | Carlsbad | California | 92011 | — |
| Wr- Pri, Llc | Encino | California | 91316 | — |
| Neuro-Pain Medical Center | Fresno | California | 93710 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| Kaizen Brain Center | La Jolla | California | 92037 | — |
| Senior Clinical Trials, Inc. | Laguna Hills | California | 92653 | — |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | — |
| USC Keck School of Medicine | Los Angeles | California | 90033 | — |
| Clinical Research Institute | Los Angeles | California | 90048 | — |
| Neurovations | Napa | California | 94558 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | — |
| SC3 Research - Pasadena | Pasadena | California | 91105 | — |
| PCND Neurology | Poway | California | 92064 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Pacific Research Network | San Diego | California | 92103 | — |
| Sharp Neurocognitive Research Center | San Diego | California | 92123 | — |
| UCSF Memory and Aging Center | San Francisco | California | 94158 | — |
| Syrentis Clinical Research | Santa Ana | California | 92705 | — |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | — |
| Tilda Research | Tustin | California | 92780 | — |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Colorado Neurological Research Center, PC | Denver | Colorado | 80210 | — |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | — |
| Yale University, Alzheimer's Disease Research Unit | New Haven | Connecticut | 06510 | — |
| Research Center for Clinical Studies | Norwalk | Connecticut | 06851 | — |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford | Connecticut | 06905 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| VIN-Julie Schwartzbard | Aventura | Florida | 33180 | — |
| Neurology Offices of South Florida | Boca Raton | Florida | 33428 | — |
| SFM Clinical Research | Boca Raton | Florida | 33487 | — |
| Brain Matters Research | Delray Beach | Florida | 33445 | — |
| Cohen Medical Associates | Delray Beach | Florida | 33446 | — |
| Integrity Clinical Research | Doral | Florida | 33166 | — |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| AGA Clinical Trials | Hialeah | Florida | 33012 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Infinity Clinical Research, LLC | Hollywood | Florida | 33024 | — |
| Encore Research Group- Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Accel Research Sites - Lakeland Clinical Research Unit | Lakeland | Florida | 33803 | — |
| ClinCloud - Maitland | Maitland | Florida | 32751 | — |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | — |
| Homestead Associates in Research | Miami | Florida | 33032 | — |
| Finlay Medical Research | Miami | Florida | 33126 | — |
| Optimus U Corporation | Miami | Florida | 33135 | — |
| Miami Jewish health | Miami | Florida | 33137 | — |
| Future Care Solution | Miami | Florida | 33142 | — |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | — |
| New Horizon Research Center | Miami | Florida | 33165 | — |
| Florida International Research Center | Miami | Florida | 33173 | — |
| Ezy Medical Research | Miami | Florida | 33175 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| The Neurology Research Group | Miami | Florida | 33176 | — |
| VIN-Victor Faradji | Miami | Florida | 33176 | — |
| Mount Sinai Cancer Center | Miami Beach | Florida | 33140 | — |
| Goji Group - Research Trials Group | Miami Lakes | Florida | 33016 | — |
| Collier Neurologic Specialists | Naples | Florida | 34105 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Synexus Clinical Research US, Inc. | Orlando | Florida | 32806 | — |
| Headlands Research Orlando | Orlando | Florida | 32819 | — |
| IMIC, Inc. | Palmetto Bay | Florida | 33157 | — |
| Emerald Coast Neurology - Airport Boulevard | Pensacola | Florida | 32504 | — |
| Quantum Laboratories Clinical Research | Pompano Beach | Florida | 33064 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | — |
| Roskamp Institute Clinical Trials Division | Sarasota | Florida | 34243 | — |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33713 | — |
| Alzheimer's Research and Treatment Center | Stuart | Florida | 34997 | — |
| Brain Matters Research | Stuart | Florida | 34997 | — |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | — |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| USF Health Byrd Alzheimer's Institute | Tampa | Florida | 33613 | — |
| Charter Research - Lady Lake | The Villages | Florida | 32162 | — |
| Synexus Clinical Research US, Inc. | The Villages | Florida | 32162 | — |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | — |
| Palm Beach Neurology | West Palm Beach | Florida | 33407 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Charter Research - Winter Park | Winter Park | Florida | 32803 | — |
| Gwinnett Research Institute | Buford | Georgia | 30519 | — |
| Columbus Memory Center, LLC | Columbus | Georgia | 31909 | — |
| NeuroStudies | Decatur | Georgia | 30030 | — |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | 60640 | — |
| AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research | Elk Grove Village | Illinois | 60007 | — |
| Advocate Medical Group | Park Ridge | Illinois | 60068 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | 46256 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010 | — |
| Covenant Medical Center | Waterloo | Iowa | 50702 | — |
| The University of Kansas - Clinical Research Center | Fairway | Kansas | 66205 | — |
| College Park Family Care Center/Multi Specialty Clinical Res | Overland Park | Kansas | 66212 | — |
| Cotton O'Neil Clinical Research Center - Central Office | Topeka | Kansas | 66606 | — |
| Ascension Via Christi Research | Wichita | Kansas | 67214 | — |
| Maine Medical Center-Maine Medical Partners Neurology | Scarborough | Maine | 04074 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | — |
| NECCR PrimaCare Research | Fall River | Massachusetts | 02721 | — |
| BTC Network | New Bedford | Massachusetts | 02740 | — |
| Boston Center for Memory | Newton | Massachusetts | 02459 | — |
| Donald S. Marks M.D., P.C. | Plymouth | Massachusetts | 02360 | — |
| Alzheimers Disease Center | Quincy | Massachusetts | 02169 | — |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Citizens Memorial Hospital District | Bolivar | Missouri | 65613 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| Sharlin Health and Neurology | Ozark | Missouri | 65721 | — |
| Arch Clinical Trials | St Louis | Missouri | 63141 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89128 | — |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | — |
| Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | 08755 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Neurological Associates Albany | Albany | New York | 12208 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| University at Buffalo - UBMD Neurology | Buffalo | New York | 14203 | — |
| Clarity Clinical Research | East Syracuse | New York | 13057 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| CHS-Behavioral Health Research | Charlotte | North Carolina | 28211 | — |
| Guilford Neurologic Associates, Inc | Greensboro | North Carolina | 27405 | — |
| AMC Research | Matthews | North Carolina | 28105 | — |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | — |
| Accellacare - Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| NeuroScience Research Center | Canton | Ohio | 44718 | — |
| Valley Medical Research | Centerville | Ohio | 45459 | — |
| Rapid Medical Research | Cleveland | Ohio | 44122 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| University of Cincinnati Physicians Company, LLC | Dayton | Ohio | 45417 | — |
| Neurology Diagnostics, Inc. | Dayton | Ohio | 45459 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Central States Research | Tulsa | Oklahoma | 74136 | — |
| Summit Headlands | Portland | Oregon | 97210 | — |
| Center for Cognitive Health | Portland | Oregon | 97225 | — |
| Abington Neurological Associates, Ltd. | Abington | Pennsylvania | 19001 | — |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Keystone Clinical Studies | Plymouth Meeting | Pennsylvania | 19462 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Prism Health Richland Department of Neurology Research | Columbia | South Carolina | 29203 | — |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | 38119 | — |
| Senior Adults Specialty Research | Austin | Texas | 78757 | — |
| Gadolin Research | Beaumont | Texas | 77702 | — |
| Kerwin Medical Center | Dallas | Texas | 75231 | — |
| Neurology Consultants of Dallas, PA | Dallas | Texas | 75243 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | — |
| Glenn Biggs Institute for Alzheimers & Neurodegenerative Diseases | San Antonio | Texas | 78229-3900 | — |
| The Memory Clinic | Bennington | Vermont | 05201-9810 | — |
| Integrated Neurology Services - Falls Church | Arlington | Virginia | 22207 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23510 | — |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| EvergreenHealth Medical Center | Kirkland | Washington | 98034 | — |
| University of Washington - Harborview Medical Center | Seattle | Washington | 98104 | — |
| Kingfisher Cooperative | Spokane | Washington | 99201 | — |
| Universal Research Group | Tacoma | Washington | 98405 | — |
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 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04437511, 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 Aug 26, 2026 · Synced Oct 26, 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 NCT04437511 live on ClinicalTrials.gov.