Skip to main content
Find more clinical trials

Donanemab for Early-Stage Alzheimer's Disease

Start: June 19, 2020
End: April 11, 2024
Enrollment: 500

What Is This Study About?

This Phase 2 clinical trial (TRAILBLAZER-ALZ 2) will test whether donanemab, also known as LY3002813, is safe and effective to slow cognitive impairment and reduce amyloid plaque in people with early-stage Alzheimer's disease. Participants will be randomly assigned to receive injections of donanemab or a placebo. The study will last about 133 weeks and may include up to 26 visits. The researchers will measure cognition as well as changes in the brain, such as amyloid plaque build-up, using MRI and positron emission tomography (PET) brain imaging scans.

Do I Qualify To Participate in This Study?

Minimum Age: 60 Years

Maximum Age: 85 Years

Must have:

  • Gradual and progressive changes in memory function for at least six months
  • Mini-Mental State Examination Score of 20 to 28
  • Presence of amyloid plaque and abnormal tau protein in the brain, signs of Alzheimer's disease, based on a PET brain scan
  • Have a study partner who can provide written informed consent for participant

Must NOT have:

  • Have conditions that prevent the safe use of MRI or PET scan, such as claustrophobia, pacemakers or other metal devices, allergy to the imaging drug, or a body weight over the instrument limits
  • Receiving antibody (immunoglobulin G therapy)
 

Who Is the General Study Contact?

For more information, visit the study website: TRAILBLAZER-ALZ 2.

Study Contact
Eli Lilly and Company
317-615-4559
Clinicaltrials.gov@lilly.com

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?

Arizona
Gilbert Neurology
Gilbert, AZ 85297
Recruiting
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Perseverance Research Center
Scottsdale, AZ 85254
Recruiting
Banner Sun Health Research Institute
Sun City, AZ 85351
Recruiting
Banner Alzheimer's Institute
Tucson, AZ 85718
Recruiting
California
North County Neurology Associates
Carlsbad, CA 92011
Recruiting
Irvine Clinical Research Center
Irvine, CA 92614
Recruiting
Anderson Clinical Research
Redlands, CA 92374
Not yet recruiting
Pacific Research Network
San Diego, CA 92103
Recruiting
Sharp Mesa Vista Hospital
San Diego, CA 92123
Recruiting
Univ of California San Francisco
San Francisco, CA 94158
Not yet recruiting
Connecticut
Institute for Neurodegenerative Disorders
New Haven, CT 06510
Recruiting
Yale University School of Medicine
New Haven, CT 06510
Not yet recruiting
New England Institute for Clinical Research
Stamford, CT 06905
Not yet recruiting
District of Columbia
Georgetown University Medical Center
Washington, DC 20007
Not yet recruiting
Florida
JEM Research Institute
Atlantis, FL 33462
Recruiting
VIN-Julie Schwartzbard
Aventura, FL 33180
Recruiting
Brain Matters Research
Delray Beach, FL 33445
Recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
Recruiting
MD Clinical
Hallandale Beach, FL 33009
Recruiting
Merritt Island Medical Research, LLC
Merritt Island, FL 32952
Recruiting
Renstar Medical Research
Ocala, FL 34471
Recruiting
Synexus Clinical Research US, Inc.
Orlando, FL 32806
Recruiting
Progressive Medical Research
Port Orange, FL 32127
Recruiting
Intercoastal Medical Group
Sarasota, FL 34239
Recruiting
Alzheimer's Research and Treatment Center
Stuart, FL 34997
Recruiting
Brain Matters Research
Stuart, FL 34997
Recruiting
Axiom Clinical Research of Florida
Tampa, FL 33609
Recruiting
Johnnie B Byrd, Sr. Alzheimer's Center and Research Institut
Tampa, FL 33613
Recruiting
Synexus - US
The Villages, FL 32162
Recruiting
Alzheimer's Research and Treatment Center
Wellington, FL 33414
Recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, FL 33407
Recruiting
Georgia
Columbus Memory Center, PC
Columbus, GA 31909
Recruiting
Illinois
Great Lakes Clinical Trials
Chicago, IL 60640
Recruiting
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, IL 60007
Not yet recruiting
Southern Illinois University School of Medicine
Springfield, IL 62702
Recruiting
Indiana
Indiana University School of Medicine
Indianapolis, IN 46202
Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, IN 46256
Recruiting
Kansas
Cotton O'Neil Clinic
Topeka, KS 66606
Recruiting
Ascension Via Christi Research
Wichita, KS 67214
Recruiting
Maine
Maine Medical Center-Maine Medical Partners Neurology
Scarborough, ME 04074
Recruiting
Massachusetts
Brigham and Women's Hospital
Boston, MA 02115
Recruiting
NECCR PrimaCare Research
Fall River, MA 02721
Recruiting
Boston Center for Memory
Newton, MA 02459
Recruiting
Donald S. Marks M.D., P.C.
Plymouth, MA 02360
Recruiting
Alzheimers Disease Center
Quincy, MA 02169
Recruiting
Adams Clinical
Watertown, MA 02472
Not yet recruiting
New Jersey
The Cognitive and Research Center of New Jersey
Springfield, NJ 07081
Recruiting
Advanced Memory Research Institute of New Jersey
Toms River, NJ 08755
Recruiting
New York
University of Buffalo
Buffalo, NY 14203
Recruiting
North Carolina
Carolinas Healthcare System
Charlotte, NC 28211
Recruiting
Alzheimer's Memory Center
Charlotte, NC 28270
Recruiting
Guilford Neurologic Associates, Inc
Greensboro, NC 27405
Recruiting
Ohio
New Horizons Clinical Research
Cincinnati, OH 45242
Recruiting
Velocity Clinical Research
Cleveland, OH 44122
Recruiting
Ohio State University Medical Center
Columbus, OH 43221
Recruiting
University of Cincinnati Health Neurology
Dayton, OH 45417
Recruiting
Neurology Diagnostics, Inc.
Dayton, OH 45459
Recruiting
Pennsylvania
Abington Neurological Associates, Ltd.
Abington, PA 19001
Recruiting
The Clinical Trial Center, LLC
Jenkintown, PA 19046
Recruiting
Keystone Clinical Studies
Norristown, PA 19403
Recruiting
University of Pennsylvania Heath System
Philadelphia, PA 19104
Not yet recruiting
Tennessee
Clinical Neuroscience Solutions PA
Memphis, TN 38119
Recruiting
Texas
Baylor AT&T Memory Center
Dallas, TX 75231
Recruiting
Neurology Consultants of Dallas, PA
Dallas, TX 75243
Recruiting
Houston Methodist Research Ins
Houston, TX 77030
Recruiting
University of Texas Health Science Center at Houston
Houston, TX 77030
Recruiting
Vermont
The Memory Clinic
Bennington, VT 05201
Recruiting

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT04437511