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Donanemab for the Prevention of Alzheimer's Disease

Start: August 27, 2021
End: November 8, 2027
Enrollment: 3300

What Is This Study About?

This Phase 3 clinical trial (TRAILBLAZER-ALZ 3) will test whether donanemab, also known as LY3002813, effectively reduces the risk of cognitive decline in people at risk for Alzheimer's disease. Participants will be randomly assigned to receive injections of the study drug or a placebo. This study will last up to three and half years. Researchers will measure cognitive function over time and track the immune response and the levels of study drug in the participants' blood.  

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 80 Years

Must have:

  • Normal cognition based on cognitive test 
  • Presence of amyloid plaques and abnormal tau protein in the brain
  • Reliable study partner and a backup partner who are familiar with the participant's overall function and behavior, such as day-to-day activities and cognitive abilities
  • Adequate literacy, vision, and hearing for neuropsychological testing at study screening
  • Males must be surgically sterile or use appropriate contraception during the study
  • Females must be infertile due to surgical sterilization, congenital anomaly, or post-menopause

Must NOT have:

  • Mild cognitive impairment, dementia, or another significant neurodegenerative disease that can affect cognition
  • Current serious or unstable illnesses that could interfere with study analysis or limit life expectancy to approximately five years
  • History of cancer with a high risk of recurrence
  • History of clinically significant or severe drug allergies, or severe post-treatment hypersensitivity reactions
  • Any condition that could make having an MRI unsafe (e.g., claustrophobia, metal implants or devices)
  • Any significant brain abnormality based on MRI or clinical laboratory test results
  • Prior treatment with anti-amyloid immunotherapy recently enough that the treatment may still be in the body 
  • Received an anti-amyloid vaccine in another study
  • Current or previous use of prescription medications for the treatment of mild cognitive impairment or Alzheimer's

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
There may be multiple sites in this clinical trial. 1-877-CT

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
Parkway Medical Center
Birmingham, AL 35215
Recruiting
Tilda Research - USAL 45
Homewood, AL 35209
Recruiting
Rehabilitation & Neurological Services
Huntsville, AL 35805
Recruiting
Arizona
Care Access - 801 South Power Road, Mesa
Mesa, AZ 85206
Recruiting
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Barrow Neurological Institute
Phoenix, AZ 85013
Recruiting
Banner Alzheimer's Institute Tucson
Tucson, AZ 85718
Recruiting
Center for Neurosciences
Tucson, AZ 85718
Recruiting
California
Option Care - Bakersfield
Bakersfield, CA 93313
Not yet recruiting
Care Access - Berkeley
Berkeley, CA 94705
Recruiting
Care Access - Beverly Hills
Beverly Hills, CA 90212
Recruiting
Velocity Clinical Research, Chula Vista
Chula Vista, CA 91911
Recruiting
Valley Clinical Trials, Inc.
Covina, CA 91723
Recruiting
Neurology Center of North Orange County
Fullerton, CA 92835
Recruiting
Care Access - Gilroy
Gilroy, CA 95020
Recruiting
Care Access - Huntington Beach
Huntington Beach, CA 92648
Recruiting
Tilda Research
Irvine, CA 92604
Recruiting
Irvine Clinical Research
Irvine, CA 92614
Recruiting
Option Care - Irvine
Irvine, CA 92618
Recruiting
Kaizen Brain Center
La Jolla, CA 92037
Recruiting
Velocity Clinical Research, San Diego
La Mesa, CA 91942
Recruiting
Healthy Brain Clinic
Long Beach, CA 90804
Recruiting
Cedars-Sinai Medical Center
Los Angeles, CA 90048
Not yet recruiting
Neurovations
Napa, CA 94558
Recruiting
Care Access - Newport Beach
Newport Beach, CA 92660
Recruiting
Valley Clinical Trials, Inc.
Northridge, CA 91325
Recruiting
Coram CVS/Specialty Infusion Services - Ontario
Ontario, CA 91761
Not yet recruiting
Velocity Clinical Research, Panorama City
Panorama City, CA 91402
Recruiting
Inland Psychiatric Medical Group
Redlands, CA 92373
Recruiting
Anderson Clinical Research
Redlands, CA 92374
Recruiting
Artemis Institute for Clinical Research
Riverside, CA 92503
Recruiting
Option Care - Riverside
Riverside, CA 92507
Recruiting
Option Care - Sacramento
Sacramento, CA 95816
Not yet recruiting
Clinical Trials Research
Sacramento, CA 95821
Recruiting
Artemis Institute for Clinical Research
San Diego, CA 92103
Recruiting
Pacific Research Network
San Diego, CA 92103
Recruiting
Coram CVS/Specialty Infusion Services - San Diego
San Diego, CA 92128
Not yet recruiting
Ray Dolby Brain Health Center
San Francisco, CA 94114
Recruiting
Care Access - Los Gatos
San Jose, CA 95124
Recruiting
Syrentis Clinical Research
Santa Ana, CA 92705
Recruiting
Care Access - Santa Clarita
Santa Clarita, CA 91321
Recruiting
Option Care - Los Angeles South
Santa Fe Springs, CA 90670
Recruiting
Providence Medical Foundation
Santa Rosa, CA 95403
Recruiting
Mazur, Statner, Dutta, Nathan
Thousand Oaks, CA 91360
Recruiting
Infect Disease Doctors Med Grp
Walnut Creek, CA 94598
Recruiting
Colorado
Care Access - Aurora
Aurora, CO 80012
Recruiting
Mountain Neurological Research Center
Basalt, CO 81621
Recruiting
Colorado Neurological Research Center, PC
Denver, CO 80210
Recruiting
Connecticut
Invicro
New Haven, CT 06510
Recruiting
Florida
JEM Research Institute
Atlantis, FL 33462
Recruiting
VIN-Julie Schwartzbard
Aventura, FL 33180
Recruiting
Neurology Offices of South Florida
Boca Raton, FL 33428
Recruiting
Excel Medical Clinical Trials
Boca Raton, FL 33434
Recruiting
SFM Clinical Research
Boca Raton, FL 33487
Recruiting
Bradenton Research Center, Inc.
Bradenton, FL 34205
Recruiting
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, FL 33765
Recruiting
Care Access - Daytona Beach
Daytona Beach, FL 32114
Recruiting
Care Access - Delray Beach
Delray Beach, FL 33484
Recruiting
Finlay Medical Research
Greenacres City, FL 33467
Recruiting
Indago Research & Health Center, Inc
Hialeah, FL 33012
Recruiting
Infinity Clinical Research, LLC
Hollywood, FL 33024
Recruiting
Jacksonville Center for Clinical Research
Jacksonville, FL 32216
Recruiting
Coram CVS/Specialty Infusion Services - Jacksonville
Jacksonville, FL 32256
Not yet recruiting
Optum Infusion - Jacksonville
Jacksonville, FL 32257
Not yet recruiting
Care Access - Guava Street
Lady Lake, FL 32159
Recruiting
Charter Research
Lady Lake, FL 32159
Recruiting
ClinCloud - Maitland
Maitland, FL 32751
Recruiting
K2 Medical Research
Maitland, FL 32751
Recruiting
ClinCloud - Viera
Melbourne, FL 32940
Recruiting
Merritt Island Medical Research, LLC
Merritt Island, FL 32952
Recruiting
Optimus U Corporation
Miami, FL 33125
Recruiting
Finlay Medical Research
Miami, FL 33126
Recruiting
VIN-Andrew Lerman
Miami, FL 33133
Recruiting
Brainstorm Research
Miami, FL 33176
Recruiting
VIN-Victor Faradji
Miami, FL 33176
Recruiting
San Marcus Research Clinic, Inc.
Miami Lakes, FL 33014
Recruiting
South Florida Research Phase I-IV
Miami Springs, FL 33166
Recruiting
Adult Medicine of Lake County
Mount Dora, FL 32757
Recruiting
Suncoast Clinical Research, Inc.
New Port Richey, FL 34652
Recruiting
Renstar Medical Research
Ocala, FL 34470
Recruiting
Headlands Research Orlando
Orlando, FL 32819
Recruiting
IMIC, Inc.
Palmetto Bay, FL 33157
Recruiting
Pines Care Research Center
Pembroke Pines, FL 33024
Recruiting
VIN- Margarita Almeida El-Ramey
Pembroke Pines, FL 33026
Recruiting
Emerald Coast Neurology - Airport Boulevard
Pensacola, FL 32504
Recruiting
Progressive Medical Research
Port Orange, FL 32127
Recruiting
Accel Research Sites - Tampa Clinical Research Unit
Saint Petersburg, FL 33709
Recruiting
Care Access - Pebble Beach Boulevard, Tampa
Sun City, FL 33573
Recruiting
Care Access - Tamarac
Tamarac, FL 33321
Recruiting
Clinical Research of West Florida
Tampa, FL 33606
Recruiting
Stedman Clinical Trials
Tampa, FL 33613
Recruiting
Olympian Clinical Research
Tampa, FL 33614
Recruiting
Vicis Clinical Research
Tampa, FL 33615
Recruiting
Coram CVS/Specialty Infusion Services - Tampa
Tampa, FL 33634
Not yet recruiting
Palm Beach Research Center
West Palm Beach, FL 33409
Recruiting
Conquest Research
Winter Park, FL 32789
Recruiting
Charter Research - Winter Park
Winter Park, FL 32792
Recruiting
Georgia
Masters of Clinical Research
Augusta, GA 30909
Recruiting
iResearch Atlanta
Decatur, GA 30030
Recruiting
Center for Advanced Research & Education
Gainesville, GA 30501
Recruiting
Meridian Clinical Research, LLC
Savannah, GA 31406
Recruiting
SKY Clinical Research Network Group-Blake
Union City, GA 30291
Recruiting
North Georgia Clinical Research
Woodstock, GA 30189
Recruiting
Idaho
Northwest Clinical Trials
Boise, ID 83704
Recruiting
Illinois
IMA Clinical Research - Chicago
Chicago, IL 60602
Recruiting
University of Chicago Medical Center
Chicago, IL 60637
Recruiting
Great Lakes Clinical Trials - Andersonville
Chicago, IL 60640
Recruiting
Uptown Research Institute
Chicago, IL 60640
Recruiting
Alexian Brothers Medical Center
Elk Grove Village, IL 60007
Recruiting
Care Access - Fairview Heights
Fairview Heights, IL 62208
Recruiting
Great Lakes Clinical Trials - Gurnee
Gurnee, IL 60031
Recruiting
Option Care - Chicago
Itasca, IL 60143
Not yet recruiting
Accellacare - DuPage
Lombard, IL 60148
Recruiting
Indiana
Coram CVS/Specialty Infusion Services - Fort Wayne
Fort Wayne, IN 46805
Recruiting
Care Access - West Indianapolis
Indianapolis, IN 46214
Recruiting
Care Access - Indianapolis
Indianapolis, IN 46236
Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, IN 46256
Recruiting
Iowa
Covenant Medical Center
Waterloo, IA 50702
Recruiting
Kansas
College Park Specialty Center
Overland Park, KS 66212
Recruiting
Kentucky
Norton Brownsboro Hospital
Louisville, KY 40241
Recruiting
Louisiana
Optum Infusion - Baton Rouge
Baton Rouge, LA 70809
Recruiting
Care Access - Lake Charles
Lake Charles, LA 70601
Recruiting
Maryland
Optum Infusion - Columbia
Columbia, MD 21046
Not yet recruiting
MD Medical Research
Oxon Hill, MD 20745
Recruiting
Massachusetts
ActivMed Practices and Research
Methuen, MA 01844
Recruiting
Boston Center for Memory
Newton, MA 02459
Recruiting
Care Access - Quincy
Quincy, MA 02171
Recruiting
MedVadis Research Corporation
Waltham, MA 02451
Recruiting
Michigan
Revival Research Institute
Sterling Heights, MI 48312
Recruiting
Minnesota
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, MN 55337
Recruiting
Coram CVS/Specialty Infusion Services - Mendota Heights
Mendota Heights, MN 55120
Recruiting
Optum Infusion - Roseville
Roseville, MN 55113
Not yet recruiting
Option Care - St. Cloud
Sauk Rapids, MN 56379
Not yet recruiting
Mississippi
SKY Clinical Research Network Group - Hall
Fayette, MS 39069
Recruiting
Quinn Healthcare/SKYCRNG
Ridgeland, MS 39157
Recruiting
Missouri
Citizens Memorial Hospital District
Bolivar, MO 65613
Recruiting
Clinical Research Professionals
Chesterfield, MO 63005
Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, MO 64111
Not yet recruiting
IMA Clinical Research - St. Louis
Saint Louis, MO 63117
Recruiting
Nevada
Coram CVS/Specialty Infusion Services - Henderson
Henderson, NV 89014
Recruiting
Option Care - Las Vegas
Las Vegas, NV 89102
Not yet recruiting
Las Vegas Medical Research
Las Vegas, NV 89113
Recruiting
New Jersey
Amici Clinical Research
Hoboken, NJ 07030
Recruiting
The Cognitive and Research Center of New Jersey
Springfield, NJ 07081
Recruiting
Amici Clinical Research LLC
Warren, NJ 07059
Recruiting
New Mexico
Albuquerque Neuroscience Inc.
Albuquerque, NM 87109
Recruiting
New York
IMA Clinical Research - Albany
Albany, NY 12205
Recruiting
Neurological Associates Albany
Albany, NY 12208
Recruiting
Prime Global Research
Bronx, NY 10456
Recruiting
Velocity Clinical Research, Syracuse
East Syracuse, NY 13057
Recruiting
IMA Clinical Research - Hartsdale
Hartsdale, NY 10530
Recruiting
IMA Clinical Research Manhattan
New York, NY 10036
Recruiting
South Shore Neurologic Associates
Patchogue, NY 11772
Recruiting
Richmond Behavioral Associates
Staten Island, NY 10314
Recruiting
North Carolina
Asheville Neurology Specialists
Asheville, NC 28806
Recruiting
Care Access - Greensboro
Greensboro, NC 27401
Recruiting
Medication Management
Greensboro, NC 27405
Recruiting
Care Access - Hope Mills
Hope Mills, NC 28348
Recruiting
Care Access Research-Kinston
Kinston, NC 28501
Recruiting
Monroe Biomedical Research
Monroe, NC 28112
Recruiting
Carteret Medical Group
Morehead City, NC 28557
Recruiting
Care Access - Charlotte
Pineville, NC 28210
Recruiting
Care Access - Raleigh
Raleigh, NC 27607
Recruiting
Accellacare - Winston-Salem
Winston-Salem, NC 27103
Recruiting
Ohio
NeuroScience Research Center
Canton, OH 44718
Recruiting
Wellnow Urgent Care and Research
Cincinnati, OH 45215
Recruiting
Neurology Diagnostics, Inc.
Dayton, OH 45459
Recruiting
Care Access - Lima
Lima, OH 45805
Recruiting
North Star Medical Research
Middleburg Heights, OH 44130
Recruiting
Option Care - Cincinnati
Milford, OH 45150
Not yet recruiting
Care Access - Youngstown
Poland, OH 44514
Recruiting
Oklahoma
Coram CVS/Specialty Infusion Services - Oklahoma City
Oklahoma City, OK 73127
Not yet recruiting
Central States Research
Tulsa, OK 74136
Recruiting
Oregon
Optum Infusion - Bend
Bend, OR 97701
Recruiting
Velocity Clinical Research - Medford
Medford, OR 97504
Recruiting
Center for Cognitive Health
Portland, OR 97225
Recruiting
Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, PA 19046
Recruiting
Suburban Research Associates
Media, PA 19063
Recruiting
Care Access - Pottsville
Pottsville, PA 17901
Recruiting
Rhode Island
Care Access - Warwick
Warwick, RI 02886
Recruiting
South Carolina
Care Access - Anderson
Anderson, SC 29621
Recruiting
Velocity Clinical Research, Anderson
Anderson, SC 29621
Recruiting
Velocity Clinical Research, Columbia
Columbia, SC 29204
Recruiting
Velocity Clinical Research, Gaffney
Gaffney, SC 29340
Recruiting
VitaLink Research - Greenville
Greenville, SC 29615
Recruiting
Care Access - Mauldin
Mauldin, SC 29662
Recruiting
Velocity Clinical Research, Spartanburg
Spartanburg, SC 29303
Recruiting
VitaLink Research - Union
Union, SC 29379
Recruiting
South Dakota
Health Concepts
Rapid City, SD 57702
Recruiting
Tennessee
Neurology Clinic, P.C.
Cordova, TN 38018
Recruiting
Clinical Neuroscience Solutions Inc
Memphis, TN 38119
Recruiting
Texas
Care Access - Austin
Austin, TX 78735
Recruiting
Texas Diabetes & Endocrinology, P.A.
Austin, TX 78749
Recruiting
Senior Adults Specialty Research
Austin, TX 78757
Recruiting
Gadolin Research
Beaumont, TX 77702
Recruiting
Headlands Research - Brownsville
Brownsville, TX 78526
Not yet recruiting
Conroe Willis Medical Research
Conroe, TX 77304
Recruiting
Advanced Neuro Research Center - ANRC
El Paso, TX 79912
Recruiting
Optum Infusion - Houston
Houston, TX 77054
Recruiting
The University of Texas Health Science Center at Houston
Houston, TX 77054
Recruiting
Next Level Urgent Care
Houston, TX 77057
Recruiting
Optum Infusion - Irving
Irving, TX 75063
Not yet recruiting
Family Practice Center
McAllen, TX 78501
Recruiting
El Faro Health and Therapeutics
Rio Grande City, TX 78582
Recruiting
Benchmark Research - Knickerbocker
San Angelo, TX 76904
Recruiting
Diagnostics Research Group
San Antonio, TX 78229
Recruiting
Consano Clinical Research, LLC
Shavano Park, TX 78231
Recruiting
Texas Valley Clinical Research
Weslaco, TX 78596
Recruiting
Utah
University of Utah Neurology
Salt Lake City, UT 84108
Recruiting
Vermont
The Memory Clinic
Bennington, VT 05201-9810
Recruiting
Virginia
Care Access - Alexandria
Alexandria, VA 22311
Recruiting
Option Care - Chantilly
Chantilly, VA 20151
Not yet recruiting
Dominion Medical Associates, Inc.
Richmond, VA 23219
Recruiting
Washington
Northwest Clinical Research Center
Bellevue, WA 98007
Recruiting
Option Care - Everett
Everett, WA 98204
Not yet recruiting
Coram CVS/Specialty Infusion Services - Spokane Valley
Spokane Valley, WA 99212
Not yet recruiting
Universal Research Group
Tacoma, WA 98405
Recruiting
Optum Infusion - Woodinville
Woodinville, WA 98072
Recruiting
West Virginia
Option Care - Charleston WV
Charleston, WV 25304
Not yet recruiting
IMA Clinical Research
Morgantown, WV 26505
Recruiting

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT05026866