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Donanemab for the Prevention of Alzheimer's Disease

Start: August 27, 2021
End: September 25, 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
1-877-CTLILLY (1-877-285-4559)

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
Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Care Access - Sun City
Sun City, AZ 85351
Recruiting
Noble Clinical Research
Tucson, AZ 85704
Not yet recruiting
Banner Alzheimer's Institute Tucson
Tucson, AZ 85718
Recruiting
Center for Neurosciences
Tucson, AZ 85718
Recruiting
California
Care Access - Beverly Hills
Beverly Hills, CA 90212
Recruiting
Valley Clinical Trials, Inc.
Covina, CA 91723
Recruiting
Marvel Clinical Research
Huntington Beach, CA 92647
Recruiting
Care Access Research - Huntington Beach
Huntington Beach, CA 92648
Recruiting
Tilda Research
Irvine, CA 92604
Recruiting
Irvine Clinical Research
Irvine, CA 92614
Recruiting
Kaizen Brain Center
La Jolla, CA 92037
Recruiting
Valley Clinical Trials, Inc.
Northridge, CA 91325
Recruiting
Anderson Clinical Research
Redlands, CA 92374
Recruiting
Artemis Institute for Clinical Research
Riverside, CA 92503
Not yet recruiting
Syrentis Clinical Research
Santa Ana, CA 92705
Recruiting
Care Access - Santa Clarita
Santa Clarita, CA 91321
Recruiting
Providence Medical Foundation
Santa Rosa, CA 95403
Not yet recruiting
Colorado
Mountain Neurological Research Center
Basalt, CO 81621
Recruiting
Alpine Clinical Research Center
Boulder, CO 80301
Recruiting
Connecticut
Institute for Neurodegenerative Disorders
New Haven, CT 06510
Not yet recruiting
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
Not yet 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
Not yet recruiting
Brain Matters Research
Delray Beach, FL 33445
Not yet recruiting
Care Access - Delray Beach
Delray Beach, FL 33484
Not yet recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
Not yet 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
Charter Research
Lady Lake, FL 32159
Recruiting
ClinCloud - Maitland
Maitland, FL 32751
Recruiting
K2 Medical Research
Maitland, FL 32751
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
The Neurology Research Group
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 34471
Recruiting
Headlands Research Orlando
Orlando, FL 32819
Recruiting
IMIC, Inc.
Palmetto Bay, FL 33157
Recruiting
VIN- Margarita Almeida El-Ramey
Pembroke Pines, FL 33026
Not yet recruiting
Emerald Coast Neurology - Airport Boulevard
Pensacola, FL 32504
Recruiting
Progressive Medical Research
Port Orange, FL 32127
Not yet recruiting
Brain Matters Research
Stuart, FL 34997
Not yet recruiting
Care Access - Pebble Beach Boulevard, Tampa
Sun City, FL 33573
Recruiting
Care Access - Tamarac
Tamarac, FL 33321
Not yet recruiting
Clinical Research of West Florida
Tampa, FL 33606
Recruiting
Axiom Clinical Research of Florida
Tampa, FL 33609
Recruiting
Stedman Clinical Trials
Tampa, FL 33613
Recruiting
Olympian Clinical Research
Tampa, FL 33614
Not yet recruiting
Accel Research Sites - Tampa Clinical Research Unit
Tampa, FL 33634
Recruiting
ClinCloud - Maitland
Viera, FL 32940
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
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
Great Lakes Clinical Trials - Arlington Heights
Arlington Heights, IL 60004
Not yet recruiting
Great Lakes Clinical Trials - Andersonville
Chicago, IL 60640
Recruiting
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, IL 60007
Recruiting
Great Lakes Clinical Trials - Gurnee
Gurnee, IL 60031
Recruiting
Indiana
Care Access - Indianapolis
Indianapolis, IN 46236
Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, IN 46256
Recruiting
Iowa
Covenant Medical Center
Waterloo, IA 50702
Recruiting
Louisiana
Care Access - Lake Charles
Lake Charles, LA 70601
Recruiting
Maryland
MD Medical Research
Oxon Hill, MD 20745
Recruiting
Massachusetts
Boston Center for Memory
Newton, MA 02459
Recruiting
MedVadis Research Corporation
Waltham, MA 02451
Recruiting
Michigan
QUEST Research Institute
Farmington Hills, MI 48334
Not yet recruiting
Mississippi
SKY Clinical Research Network Group-Quinn
Ridgeland, MS 39157
Recruiting
Missouri
Citizens Memorial Hospital District
Bolivar, MO 65613
Not yet recruiting
Clinical Research Professionals
Chesterfield, MO 63005
Recruiting
Sharlin Health Neuroscience Research Center
Ozark, MO 65721
Recruiting
Nevada
Las Vegas Medical Research
Las Vegas, NV 89113
Recruiting
Neurology Research Institute
Las Vegas, NV 89128
Recruiting
New Jersey
The Cognitive and Research Center of New Jersey
Springfield, NJ 07081
Recruiting
New York
Prime Global Research
Bronx, NY 10456
Recruiting
Clarity Clinical Research
East Syracuse, NY 13057
Recruiting
South Shore Neurologic Associates
Patchogue, NY 11772
Recruiting
North Carolina
CHS-Behavioral Health Research
Charlotte, NC 28211
Not yet recruiting
Medication Management
Greensboro, NC 27408
Recruiting
Care Access - Kinston
Kinston, NC 28501
Recruiting
Oklahoma
Central States Research
Tulsa, OK 74136
Recruiting
Oregon
Summit Research Network
Portland, OR 97210
Not yet recruiting
Center for Cognitive Health
Portland, OR 97225
Recruiting
Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, PA 19046
Recruiting
Rhode Island
Care Access - Warwick
Warwick, RI 02886
Recruiting
South Carolina
VitaLink Research - Columbia
Columbia, SC 29204
Recruiting
VitaLink Research - Greenville
Greenville, SC 29615
Recruiting
VitaLink Research - Spartanburg
Spartanburg, SC 29303
Recruiting
VitaLink Research - Union
Union, SC 29379
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
Gadolin Research
Beaumont, TX 77702
Recruiting
Kerwin Medical Center
Dallas, TX 75231
Not yet recruiting
El Paso Medical Research Institute
El Paso, TX 79902
Not yet recruiting
The University of Texas Health Science Center at Houston
Houston, TX 77054
Recruiting
Next Level Urgent Care
Houston, TX 77057
Recruiting
Benchmark Research - Knickerbocker
San Angelo, TX 76904
Recruiting
Consano Clinical Research, LLC
Shavano Park, TX 78231
Recruiting
Utah
University of Utah Neurology
Salt Lake City, UT 84108
Not yet recruiting
Vermont
The Memory Clinic
Bennington, VT 05201-9810
Recruiting
Virginia
Dominion Medical Associates, Inc.
Richmond, VA 23219
Recruiting
Washington
Northwest Clinical Research Center
Bellevue, WA 98007
Not yet recruiting
Universal Research Group
Tacoma, WA 98405
Recruiting

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT05026866