Donanemab for the Prevention of Alzheimer's Disease

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?

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.

 

Where Is This Study Located?

Alabama
Parkway Medical Center Birmingham, AL 35215 Recruiting James Gregory "Greg" Sullivan
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive Homewood, AL 35209 Recruiting Michael Falola
Rehabilitation & Neurological Services Huntsville, AL 35805 Recruiting Belinda Savage-Edwards, MD
Arizona
Care Access - 801 South Power Road, Mesa Mesa, AZ 85206 Recruiting Victoria Horstman
Banner Alzheimer's Institute Phoenix, AZ 85006 Recruiting David Weidman
Barrow Neurological Institute Phoenix, AZ 85013 Recruiting Anna Burke
Banner Alzheimer's Institute Tucson Tucson, AZ 85718 Recruiting Allan A Anderson
Center for Neurosciences Tucson, AZ 85718 Recruiting Michael A Badruddoja
California
Option Care - Bakersfield Bakersfield, CA 93313 Not yet recruiting Collins Liu
Care Access - Berkeley Berkeley, CA 94705 Recruiting Christine Thai
Care Access - Beverly Hills Beverly Hills, CA 90212 Recruiting Phillip Bowman
Velocity Clinical Research, Chula Vista Chula Vista, CA 91911 Recruiting Michael Waters
Valley Clinical Trials, Inc. Covina, CA 91723 Recruiting Masoud Mohammed Azizad
Neurology Center of North Orange County Fullerton, CA 92835 Recruiting Anthony Ciabarra
Care Access - Gilroy Gilroy, CA 95020 Recruiting Christine Thai
Care Access Research - Huntington Beach Huntington Beach, CA 92648 Recruiting Christine Thai
Tilda Research Irvine, CA 92612 Recruiting Juan Velez
Irvine Clinical Research Irvine, CA 92614 Recruiting Elly R Lee
Option Care - Irvine Irvine, CA 92618 Recruiting Eric Grigsby
Kaizen Brain Center La Jolla, CA 92037 Recruiting Collins Liu
Velocity Clinical Research, San Diego La Mesa, CA 91942 Recruiting J. Scott Overcash
Healthy Brain Clinic Long Beach, CA 90804 Recruiting Dung Trinh
Cedars-Sinai Medical Center Los Angeles, CA 90048 Not yet recruiting Sarah Kremen
Neurovations Napa, CA 94558 Recruiting Eric Grigsby
Care Access - Newport Beach Newport Beach, CA 92660 Recruiting Christine Thai
Valley Clinical Trials, Inc. Northridge, CA 91325 Recruiting Masoud Mohammed Azizad
Coram CVS/Specialty Infusion Services - Ontario Ontario, CA 91761 Not yet recruiting Masoud Mohammed Azizad
Velocity Clinical Research, Panorama City Panorama City, CA 91402 Recruiting Robert Allen Jenders
Inland Psychiatric Medical Group Redlands, CA 92373 Recruiting Juan Velez
Anderson Clinical Research Redlands, CA 92374 Recruiting Donald Lee Anderson
Artemis Institute for Clinical Research Riverside, CA 92503 Recruiting Eric Michael Chavez
Option Care - Riverside Riverside, CA 92507 Recruiting Christine Thai
Option Care - Sacramento Sacramento, CA 95816 Recruiting Eric Grigsby
Clinical Trials Research Sacramento, CA 95821 Recruiting Jeffrey D Wayne
Artemis Institute for Clinical Research San Diego, CA 92103 Recruiting Eric Michael Chavez
Pacific Research Network San Diego, CA 92103 Recruiting Stephen G Thein
Coram CVS/Specialty Infusion Services - San Diego San Diego, CA 92128 Not yet recruiting Masoud Mohammed Azizad
Ray Dolby Brain Health Center San Francisco, CA 94114 Recruiting Armen J Moughamian
Care Access - Los Gatos San Jose, CA 95124 Recruiting Christine Thai
Syrentis Clinical Research Santa Ana, CA 92705 Recruiting John Gregory Duffy
Care Access - Santa Clarita Santa Clarita, CA 91321 Recruiting Sina Tebi
Option Care - Los Angeles South Santa Fe Springs, CA 90670 Recruiting Collins Liu
Providence Medical Foundation Santa Rosa, CA 95403 Recruiting Allan L Bernstein
Infectious Disease Doctors Medical Group, APC Walnut Creek, CA 94598 Recruiting Bhavna Malik
Colorado
Care Access - Aurora Aurora, CO 80012 Recruiting Sinikka Liisa Green
Mountain Neurological Research Center Basalt, CO 81621 Recruiting Alison B Allen
Colorado Neurological Research Center, PC Denver, CO 80210 Recruiting Adam J Wolff
Connecticut
Invicro New Haven, CT 06510 Recruiting David S Russell
Florida
JEM Research Institute Atlantis, FL 33462 Recruiting Mark A Goldstein
VIN-Julie Schwartzbard Aventura, FL 33180 Recruiting Julie Schwartzbard
Neurology Offices of South Florida Boca Raton, FL 33428 Recruiting Brian A Costell
Excel Medical Clinical Trials Boca Raton, FL 33434 Recruiting Seth J. Baum
SFM Clinical Research Boca Raton, FL 33487 Recruiting Marc Feinberg
Bradenton Research Center, Inc. Bradenton, FL 34205 Recruiting Eric Folkens
Clinical Research of West Florida, Inc. (Clearwater) Clearwater, FL 33765 Recruiting Leonard Jay Dunn
Care Access - Daytona Beach Daytona Beach, FL 32114 Recruiting Brad Lipson
Care Access - Delray Beach Delray Beach, FL 33484 Recruiting Brad Lipson
Finlay Medical Research Greenacres City, FL 33467 Recruiting Jorge J Calle Medina
Indago Research & Health Center, Inc Hialeah, FL 33012 Recruiting Jose Francisco Cardona
Infinity Clinical Research, LLC Hollywood, FL 33024 Recruiting Harvey Schwartz
Encore Research Group- Jacksonville Center for Clinical Research Jacksonville, FL 32216 Recruiting Steven A Toenjes
Coram CVS/Specialty Infusion Services - Jacksonville Jacksonville, FL 32256 Not yet recruiting Brandon Lenox
Care Access - Guava Street Lady Lake, FL 32159 Recruiting Brad Lipson
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit Largo, FL 33777 Recruiting Deborah Burke
ClinCloud - Maitland Maitland, FL 32751 Recruiting Esteban Olivera
K2 Medical Research Maitland, FL 32751 Recruiting Brandon Lenox
ClinCloud - Viera Melbourne, FL 32940 Recruiting Rosemary Laird
Merritt Island Medical Research, LLC Merritt Island, FL 32952 Recruiting Gregory Kirk
Optimus U Corporation Miami, FL 33125 Recruiting Yaneicy Gonzalez Rojas
Finlay Medical Research Miami, FL 33126 Recruiting Lilia Rodriguez Ables
VIN-Andrew Lerman Miami, FL 33133 Recruiting Andrew Lerman
IMIC, Inc. Miami, FL 33176 Recruiting Ramon Leon
The Neurology Research Group Miami, FL 33176 Recruiting Brad Herskowitz
VIN-Victor Faradji Miami, FL 33176 Recruiting Victor Faradji
San Marcus Research Clinic, Inc. Miami Lakes, FL 33014 Recruiting MARIA CUESTA TORRES
South Florida Research Phase I-IV Miami Springs, FL 33166 Recruiting Belkis Delgado
Adult Medicine of Lake County Mount Dora, FL 32757 Recruiting Shirley A. Nagel
Suncoast Clinical Research, Inc. New Port Richey, FL 34652 Recruiting Cathy Barnes
Renstar Medical Research Ocala, FL 34470 Recruiting Anette V. Nieves
Headlands Research Orlando Orlando, FL 32819 Recruiting christopher Galloway
Pines Care Research Center, LLC Pembroke Pines, FL 33024 Recruiting Jaynier Moya
VIN- Margarita Almeida El-Ramey Pembroke Pines, FL 33026 Recruiting Margarita Almeida El-Ramey
Emerald Coast Neurology - Airport Boulevard Pensacola, FL 32504 Recruiting David M Bear
Progressive Medical Research Port Orange, FL 32127 Recruiting Alexander J. White
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit Saint Petersburg, FL 33709 Recruiting Deborah Burke
Care Access - Pebble Beach Boulevard, Tampa Sun City, FL 33573 Recruiting Brad Lipson
Care Access - Tamarac Tamarac, FL 33321 Recruiting Brad Lipson
Stedman Clinical Trials Tampa, FL 33613 Recruiting Mary Stedman
Vicis Clinical Research Tampa, FL 33615 Recruiting Hector R Fuentes- Colon
Coram CVS/Specialty Infusion Services - Tampa Tampa, FL 33634 Recruiting Brandon Lenox
Clinical Research of West Florida Tampa, FL 33606 Recruiting Lon D. Lynn, DO
K2 Medical Research - Tampa Tampa, FL 33607 Recruiting Kelley Wilson Yokum
Charter Research - Lady Lake The Villages, FL 32162 Recruiting Jeffrey A Norton
Palm Beach Research Center West Palm Beach, FL 33409 Recruiting Pamela Kane
Conquest Research Winter Park, FL 32789 Recruiting Rekha Gandhi
Charter Research - Winter Park Winter Park, FL 32792 Recruiting Edgardo J Rivera-Rivera
Georgia
Masters of Clinical Research Augusta, GA 30909 Recruiting Amy Sprague
iResearch Atlanta Decatur, GA 30030 Recruiting Kimball A. Johnson
Center for Advanced Research & Education Gainesville, GA 30501 Recruiting Angela Dawn Ritter
Meridian Clinical Research, LLC Savannah, GA 31406 Recruiting John Michael Hemphill
Rophe Adult and Pediatric Medicine/SKYCRNG Union City, GA 30291 Recruiting Dwight Blake
North Georgia Clinical Research Woodstock, GA 30189 Recruiting Bram Wieskopf
Idaho
Northwest Clinical Trials Boise, ID 83704 Recruiting Brock Aaron McConnehey
Illinois
IMA Clinical Research - Chicago Chicago, IL 60602 Recruiting Benjamin Lumicao
University of Chicago Medical Center Chicago, IL 60637 Recruiting James Mastrianni
Great Lakes Clinical Trials - Andersonville Chicago, IL 60640 Recruiting Jeffrey S. Ross
Uptown Research Institute Chicago, IL 60640 Recruiting Michael Jutovsky
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research Elk Grove Village, IL 60007 Recruiting Concetta M. Forchetti
Care Access - Fairview Heights Fairview Heights, IL 62208 Recruiting Phyllis D Marx
Great Lakes Clinical Trials - Gurnee Gurnee, IL 60031 Recruiting Jeffrey S. Ross
Option Care - Chicago Itasca, IL 60143 Not yet recruiting Benjamin Lumicao
Accellacare - DuPage Lombard, IL 60148 Recruiting Yoko Momoyama
Indiana
Coram CVS/Specialty Infusion Services - Fort Wayne Fort Wayne, IN 46805 Recruiting Steven Donis Smith
Care Access - West Indianapolis Indianapolis, IN 46214 Recruiting Steven Donis Smith
Care Access - Indianapolis Indianapolis, IN 46236 Recruiting Steven Donis Smith
Josephson Wallack Munshower Neurology, PC Indianapolis, IN 46256 Recruiting Kristi Koch George
Iowa
Covenant Medical Center Waterloo, IA 50702 Recruiting Nicholas JAMES Goetsch
Kansas
College Park Specialty Center Overland Park, KS 66212 Recruiting Jeffrey M Kaplan
Kentucky
Norton Brownsboro Hospital Louisville, KY 40241 Recruiting Gregory E Cooper Ph.D., M.D.
Louisiana
Optum Infusion - Baton Rouge Baton Rouge, LA 70809 Recruiting Jason Morris
Care Access - Lake Charles Lake Charles, LA 70601 Recruiting Jason Morris
Maryland
Optum Infusion - Columbia Columbia, MD 21046 Not yet recruiting Stephen Ong
MD Medical Research Oxon Hill, MD 20745 Recruiting Stephen Ong
Massachusetts
Care Access - Dorchester Dorchester, MA 02124 Recruiting Chih Chao (Justin) Yang
ActivMed Practices and Research Methuen, MA 01844 Recruiting Michael J. McCartney
Boston Center for Memory Newton, MA 02459 Recruiting Paul R Solomon
MedVadis Research Corporation Waltham, MA 02451 Recruiting David DiBenedetto
Michigan
Revival Research Institute Sterling Heights, MI 48312 Recruiting Abdulhassan Saad
Minnesota
Minneapolis Clinic of Neurology - Burnsville Office Burnsville, MN 55337 Recruiting Rajiv Aggarwal
Coram CVS/Specialty Infusion Services - Mendota Heights Mendota Heights, MN 55120 Recruiting Sinikka Liisa Green
Optum Infusion - Roseville Roseville, MN 55113 Not yet recruiting Rajiv Aggarwal
Option Care - St. Cloud Sauk Rapids, MN 56379 Not yet recruiting Rajiv Aggarwal
Mississippi
SKY Clinical Research Network Group - Hall Fayette, MS 39069 Recruiting James B. Hall, MD
SKY Integrative Medical Center/SKYCRNG Ridgeland, MS 39157 Recruiting Timothy Quinn
Missouri
Citizens Memorial Hospital District Bolivar, MO 65613 Recruiting Curtis P. Schreiber
Clinical Research Professionals Chesterfield, MO 63005 Recruiting Siddharth Kaul
IMA Clinical Research - St. Louis Saint Louis, MO 63117 Recruiting Michael Reschak
Nevada
Coram CVS/Specialty Infusion Services - Henderson Henderson, NV 89014 Recruiting Bharat R Mocherla
Option Care - Las Vegas Las Vegas, NV 89102 Recruiting Bharat R Mocherla
Las Vegas Medical Research Las Vegas, NV 89113 Recruiting Bharat R Mocherla
New Jersey
Amici Clinical Research Hoboken, NJ 07030 Recruiting Robert Stephen Falcone
The Cognitive and Research Center of New Jersey Springfield, NJ 07081 Recruiting Michelle Papka
Amici Clinical Research LLC Warren, NJ 07059 Recruiting Robert Stephen Falcone
New Mexico
Albuquerque Neuroscience Inc. Albuquerque, NM 87109 Recruiting Daniel Allen Collins
New York
IMA Clinical Research - Albany Albany, NY 12205 Recruiting Robert Stephen Falcone
Neurological Associates Albany Albany, NY 12208 Recruiting Richard Holub
Prime Global Research Bronx, NY 10456 Recruiting Ruby Hussain
Clarity Clinical Research East Syracuse, NY 13057 Recruiting Robert Carmen Cupelo
IMA Clinical Research - Hartsdale Hartsdale, NY 10530 Recruiting Nader Zaki
IMA Clinical Research New York, NY 10036 Recruiting Robert Stephen Falcone
South Shore Neurologic Associates Patchogue, NY 11772 Recruiting Mark Gudesblatt
Richmond Behavioral Associates Staten Island, NY 10314 Recruiting Mark Vincent DiBuono
North Carolina
Asheville Neurology Specialists Asheville, NC 28806 Recruiting Matthew Engelbrecht
Care Access - Greensboro Greensboro, NC 27401 Recruiting Eric Ibegbu, M.D., FACG, FASGE
Medication Management Greensboro, NC 27405 Recruiting James Donald Franklin
Care Access - Hope Mills Hope Mills, NC 28348 Recruiting Eric Ibegbu, M.D., FACG, FASGE
Care Access - Kinston Kinston, NC 28501 Recruiting Eric Ibegbu, M.D., FACG, FASGE
Monroe Biomedical Research Monroe, NC 28112 Recruiting Awawu Igbinadolor
Carteret Medical Group Morehead City, NC 28557 Recruiting Mary Katherine Lawrence
Care Access - Charlotte Pineville, NC 28210 Recruiting Eric Ibegbu, M.D., FACG, FASGE
Care Access - Raleigh Raleigh, NC 27607 Recruiting Eric Ibegbu, M.D., FACG, FASGE
Accellacare - Winston-Salem Winston-Salem, NC 27103 Recruiting Mitchell Gareth Isaac
Ohio
NeuroScience Research Center Canton, OH 44718 Recruiting Ryan S Drake
Wellnow Urgent Care and Research Cincinnati, OH 45215 Recruiting Blaise Gatto
Neurology Diagnostics, Inc. Dayton, OH 45459 Recruiting Joel Vandersluis
Care Access - Lima Lima, OH 45805 Recruiting Steven Donis Smith
North Star Medical Research Middleburg Heights, OH 44130 Recruiting Mark Joseph Woyshville
Option Care - Cincinnati Milford, OH 45150 Not yet recruiting Blaise Gatto
Care Access - Youngstown Poland, OH 44514 Recruiting Sayed M. Yossef
Oklahoma
Central States Research Tulsa, OK 74136 Recruiting Sarah Land
Oregon
Optum Infusion - Bend Bend, OR 97701 Recruiting Michael Steven Mega
Velocity Clinical Research, Medford Medford, OR 97504 Recruiting Sarah Smiley
Center for Cognitive Health Portland, OR 97225 Recruiting Michael Steven Mega
Pennsylvania
The Clinical Trial Center, LLC Jenkintown, PA 19046 Recruiting Marvin Kalafer
Suburban Research Associates Media, PA 19063 Recruiting Shivkumar S Hatti
Care Access - Pottsville Pottsville, PA 17901 Recruiting Glenn Freed
Rhode Island
Care Access Research - Warwick Warwick, RI 02886 Recruiting Sudhir Bansal
South Carolina
Care Access - Anderson Anderson, SC 29621 Recruiting Anne Tuggle
Velocity Clinical Research, Anderson Anderson, SC 29621 Recruiting Charles Thompson
VitaLink Research - Columbia Columbia, SC 29204 Recruiting Gregory Feldman
Velocity Clinical Research, Gaffney Gaffney, SC 29340 Recruiting David Erb
VitaLink Research - Greenville Greenville, SC 29615 Recruiting Luis de la Cruz
Care Access - Mauldin Mauldin, SC 29662 Recruiting Anne Tuggle
VitaLink Research - Spartanburg Spartanburg, SC 29303 Recruiting Farhan Siddiqui
VitaLink Research - Union Union, SC 29379 Recruiting Joseph Boscia
South Dakota
Health Concepts Rapid City, SD 57702 Recruiting Richard Beasley
Tennessee
Neurology Clinic, P.C. Cordova, TN 38018 Recruiting Thomas W Arnold
Clinical Neuroscience Solutions Inc. Memphis, TN 38119 Recruiting Lora J. McGill
Texas
Care Access - Austin Austin, TX 78735 Recruiting Sinikka Liisa Green
Texas Diabetes & Endocrinology, P.A. Austin, TX 78749 Recruiting Andrea Raymond
Senior Adults Specialty Research Austin, TX 78757 Recruiting Jaron L Winston
Gadolin Research Beaumont, TX 77702 Recruiting Jason Mensah
Headlands Research - Brownsville Brownsville, TX 78526 Recruiting Christopher Romero
Conroe Willis Medical Research Conroe, TX 77304 Recruiting Robert Jeremy Laningham
Advanced Neuro Research Center - ANRC El Paso, TX 79912 Recruiting Aamr Aamr Herekar
Optum Infusion - Houston Houston, TX 77054 Recruiting Robert Jeremy Laningham
The University of Texas Health Science Center at Houston Houston, TX 77054 Recruiting Paul Ernest Schulz
Next Level Urgent Care Houston, TX 77057 Recruiting Wilner Jeudy
Optum Infusion - Irving Irving, TX 75063 Not yet recruiting Jason Mensah
Family Practice Center McAllen, TX 78501 Recruiting Manuel Josue Sanchez, MD
El Faro Health and Therapeutics Rio Grande City, TX 78582 Recruiting James Antonio Falcon
Benchmark Research - Knickerbocker San Angelo, TX 76904 Recruiting Darrell T. Herrington
Diagnostics Research Group San Antonio, TX 78229 Recruiting John R. Holcomb
Consano Clinical Research, LLC Shavano Park, TX 78231 Recruiting Michelle Welch
Texas Valley Clinical Research Weslaco, TX 78596 Recruiting Eduardo Dusty Luna
Vermont
The Memory Clinic Bennington, VT 05201-9810 Recruiting Cynthia Murphy
Virginia
Care Access - Alexandria Alexandria, VA 22311 Recruiting Jason Robert Begue
Option Care - Chantilly Chantilly, VA 20151 Recruiting Richard Jackson
Dominion Medical Associates, Inc. Richmond, VA 23219 Recruiting Richard Jackson
Washington
Northwest Clinical Research Center Bellevue, WA 98007 Recruiting Arifulla Khan, MD
Option Care - Everett Everett, WA 98204 Not yet recruiting Sabrina Ann Benjamin
Coram CVS/Specialty Infusion Services - Spokane Valley Spokane Valley, WA 99212 Not yet recruiting Arifulla Khan, MD
Universal Research Group Tacoma, WA 98405 Recruiting Sabrina Ann Benjamin
Optum Infusion - Woodinville Woodinville, WA 98072 Recruiting Arifulla Khan, MD
West Virginia
Option Care - Charleston WV Charleston, WV 25304 Not yet recruiting WARD J PAINE
Exemplar Research Morgantown, WV 26505 Recruiting WARD J PAINE

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT05026866