A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

April 18, 2024 updated by: Eli Lilly and Company

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Japan
      • Tokyo, Japan, 104-0031
        • Active, not recruiting
        • Tokyo Asbo Clinic
    • Aichi
      • Obu, Aichi, Japan, 474-8511
        • Active, not recruiting
        • National Center for Geriatrics and Gerontology
    • Oita
      • Yufu, Oita, Japan, 879-5593
        • Active, not recruiting
        • Oita University Hospital
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Active, not recruiting
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8654
        • Active, not recruiting
        • The University of Tokyo Hospital
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Active, not recruiting
        • Fukuwa Clinic
      • Shinjuku, Tokyo, Japan, 160-0017
        • Active, not recruiting
        • Samoncho Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Recruiting
        • Heishinkai Medical Group ToCROM Clinic
        • Principal Investigator:
          • Osamu Matsuoka
        • Contact:
          • Phone Number: 18446887036
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Recruiting
        • SCB Research Center
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • William Julio
      • Caguas, Puerto Rico, 00727
        • Recruiting
        • Dr. Samuel Sanchez PSC
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Karen Cruz
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Mindful Medical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Oscar Soto-Raices
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • INSPIRA Clinical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Yvette Marie Cruz-Pagan
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Instituto De Neurologia Dra. Ivonne Fraga
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Ivonne Fraga
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Ivonne Z Jimenez-Velazquez
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Recruiting
        • Parkway Medical Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • James Gregory "Greg" Sullivan
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Michael Falola
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Rehabilitation & Neurological Services
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Belinda Savage-Edwards, MD
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Care Access - 801 South Power Road, Mesa
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Victoria Horstman
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner Alzheimer's Institute
        • Principal Investigator:
          • David Weidman
        • Contact:
          • Phone Number: 844-688-7036
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Anna Burke
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Banner Alzheimer's Institute Tucson
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Allan A Anderson
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Velocity Clinical Research, Providence
        • Principal Investigator:
          • Michael A Badruddoja
    • California
      • Bakersfield, California, United States, 93313
        • Not yet recruiting
        • Option Care - Bakersfield
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • MOHAMMED MUZAMMIL AHMED
      • Berkeley, California, United States, 94705
        • Recruiting
        • Care Access - Berkeley
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Care Access - Beverly Hills
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Phillip Bowman
      • Chula Vista, California, United States, 91911
        • Completed
        • Velocity Clinical Research, Chula Vista
      • Covina, California, United States, 91723
        • Recruiting
        • Valley Clinical Trials, Inc.
        • Principal Investigator:
          • Masoud Mohammed Azizad
      • Fullerton, California, United States, 92835
        • Recruiting
        • Neurology Center of North Orange County
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Anthony Ciabarra
      • Gilroy, California, United States, 95020
        • Recruiting
        • Care Access - Gilroy
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Care Access Research - Huntington Beach
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Irvine, California, United States, 92618
        • Recruiting
        • Option Care - Irvine
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Eric J Grigsby
      • La Jolla, California, United States, 92037
        • Completed
        • Kaizen Brain Center
      • La Mesa, California, United States, 91942
        • Recruiting
        • Velocity Clinical Research, San Diego
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • J. Scott Overcash
      • Long Beach, California, United States, 90804
        • Recruiting
        • Healthy Brain Clinic
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Dung Trinh
      • Napa, California, United States, 94558
        • Recruiting
        • Neurovations
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Eric J Grigsby
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Care Access - Newport Beach
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials, Inc.
        • Principal Investigator:
          • Masoud Mohammed Azizad
        • Contact:
          • Phone Number: 18446887036
      • Ontario, California, United States, 91761
        • Not yet recruiting
        • Coram CVS/Specialty Infusion Services - Ontario
        • Principal Investigator:
          • Masoud Mohammed Azizad
        • Contact:
          • Phone Number: 18446887036
      • Panorama City, California, United States, 91402
        • Recruiting
        • Velocity Clinical Research, Panorama City
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Robert Allen Jenders
      • Redlands, California, United States, 92374
        • Recruiting
        • Anderson Clinical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Donald Lee Anderson
      • Redlands, California, United States, 92373
        • Recruiting
        • Inland Psychiatric Medical Group
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • MEHUL SHAILESH SONAWALA
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Eric Michael Chavez
      • Riverside, California, United States, 92507
        • Recruiting
        • Option Care - Riverside
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Sacramento, California, United States, 95821
        • Recruiting
        • Clinical Trials Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jeffrey D Wayne
      • Sacramento, California, United States, 95816
        • Recruiting
        • Option Care - Sacramento
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Eric J Grigsby
      • San Diego, California, United States, 92103
        • Recruiting
        • Artemis Institute for Clinical Research
        • Principal Investigator:
          • Eric Michael Chavez
      • San Diego, California, United States, 92128
        • Not yet recruiting
        • Coram CVS/Specialty Infusion Services - San Diego
        • Principal Investigator:
          • Masoud Mohammed Azizad
        • Contact:
          • Phone Number: 18446887036
      • San Diego, California, United States, 92103
        • Completed
        • Pacific Research Network
      • San Francisco, California, United States, 94114
        • Recruiting
        • Ray Dolby Brain Health Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Armen J Moughamian
      • San Jose, California, United States, 95124
        • Recruiting
        • Care Access - Los Gatos
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christine Thai
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
        • Principal Investigator:
          • John Gregory Duffy
      • Santa Clarita, California, United States, 91321
        • Recruiting
        • Care Access - Santa Clarita
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Sina Tebi
      • Santa Fe Springs, California, United States, 90670
        • Completed
        • Option Care - Los Angeles South
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Allan L Bernstein
      • Thousand Oaks, California, United States, 91360
        • Completed
        • Mazur, Statner, Dutta, Nathan, PC
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Infectious Disease Doctors Medical Group, APC
        • Principal Investigator:
          • Bhavna Malik
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Care Access - Aurora
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Sinikka Liisa Green
      • Basalt, Colorado, United States, 81621
        • Recruiting
        • Mountain Neurological Research Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Alison B Allen
      • Denver, Colorado, United States, 80210
        • Active, not recruiting
        • Colorado Neurological Research Center, PC
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Invicro
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • David S Russell
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Mark A Goldstein
      • Aventura, Florida, United States, 33180
        • Recruiting
        • VIN-Julie Schwartzbard
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Julie Schwartzbard
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Rasha Youssef
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Neurology Offices of South Florida
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brian A Costell
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • SFM Clinical Research
        • Principal Investigator:
          • Marc Feinberg
        • Contact:
          • Phone Number: 844-688-7036
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Bradenton Research Center, Inc.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Eric Folkens
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida, Inc. (Clearwater)
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Leonard Jay Dunn
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Care Access - Daytona Beach
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Lipson
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Care Access - Delray Beach
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Lipson
      • Greenacres City, Florida, United States, 33467
        • Recruiting
        • Finlay Medical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jorge J Calle Medina
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Indago Research & Health Center, Inc
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Jose Francisco Cardona
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Infinity Clinical Research, LLC
        • Principal Investigator:
          • Harvey Schwartz
        • Contact:
          • Phone Number: 844-688-7036
      • Jacksonville, Florida, United States, 32256
        • Not yet recruiting
        • Coram CVS/Specialty Infusion Services - Jacksonville
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brandon Lenox
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Encore Research Group- Jacksonville Center for Clinical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Steven A Toenjes
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • Care Access - Guava Street
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Lipson
      • Largo, Florida, United States, 33777
        • Recruiting
        • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Deborah Burke
      • Maitland, Florida, United States, 32751
        • Recruiting
        • ClinCloud - Maitland
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Esteban Olivera
      • Melbourne, Florida, United States, 32940
        • Recruiting
        • ClinCloud - Viera
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Rosemary Laird
      • Merritt Island, Florida, United States, 32952
        • Recruiting
        • Merritt Island Medical Research, LLC
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Gregory Kirk
      • Miami, Florida, United States, 33125
        • Recruiting
        • Optimus U Corporation
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Yaneicy Gonzalez Rojas
      • Miami, Florida, United States, 33133
        • Recruiting
        • VIN-Andrew Lerman
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Andrew Lerman
      • Miami, Florida, United States, 33126
        • Recruiting
        • Finlay Medical Research
        • Principal Investigator:
          • Lilia Rodriguez Ables
      • Miami, Florida, United States, 33176
        • Recruiting
        • VIN-Victor Faradji
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Victor Faradji
      • Miami, Florida, United States, 33176
        • Recruiting
        • The Neurology Research Group
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Herskowitz
      • Miami, Florida, United States, 33176
        • Recruiting
        • IMIC, Inc.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Ramon Leon
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • San Marcus Research Clinic, Inc.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • MARIA CUESTA TORRES
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV
        • Principal Investigator:
          • Belkis Delgado
        • Contact:
          • Phone Number: 844-688-7036
      • Mount Dora, Florida, United States, 32757
        • Recruiting
        • Adult Medicine of Lake County
        • Principal Investigator:
          • Shirley A. Nagel
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Anette V. Nieves
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Headlands Research Orlando
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Theodore Lee
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • VIN- Margarita Almeida El-Ramey
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Margarita Almeida El-Ramey
      • Pembroke Pines, Florida, United States, 33024
        • Completed
        • Pines Care Research Center, LLC
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Emerald Coast Neurology - Airport Boulevard
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • David M Bear
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Alexander J. White
      • Sun City, Florida, United States, 33573
        • Recruiting
        • Care Access - Pebble Beach Boulevard, Tampa
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Lipson
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Care Access - Tamarac
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brad Lipson
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Lon D. Lynn, DO
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Stedman Clinical Trials
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Mary Stedman
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Vicis Clinical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Hector R Fuentes- Colon
      • Tampa, Florida, United States, 33634
        • Recruiting
        • Coram CVS/Specialty Infusion Services - Tampa
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Brandon Lenox
      • Tampa, Florida, United States, 33607
        • Recruiting
        • K2 Medical Research - Tampa
        • Principal Investigator:
          • Kelley Wilson Yokum
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake
        • Principal Investigator:
          • Jeffrey A Norton
      • West Palm Beach, Florida, United States, 33409
        • Recruiting
        • Palm Beach Research Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Pamela Kane
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Rekha Gandhi
      • Winter Park, Florida, United States, 32792
        • Recruiting
        • Charter Research - Winter Park
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Edgardo J Rivera-Rivera
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Masters of Clinical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Amy Sprague
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Kimball A. Johnson
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Center for Advanced Research & Education
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Angela Dawn Ritter
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Meridian Clinical Research, LLC
        • Principal Investigator:
          • John Michael Hemphill
      • Union City, Georgia, United States, 30291
        • Recruiting
        • Rophe Adult and Pediatric Medicine/SKYCRNG
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Dwight Blake
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Bram Wieskopf
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Northwest Clinical Trials
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Brock Aaron McConnehey
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • James Mastrianni
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials - Andersonville
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jeffrey S. Ross
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Uptown Research Institute
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Michael Jutovsky
      • Chicago, Illinois, United States, 60602
        • Recruiting
        • IMA Clinical Research - Chicago
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Benjamin Lumicao
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
        • Principal Investigator:
          • Concetta M. Forchetti
      • Fairview Heights, Illinois, United States, 62208
        • Recruiting
        • Care Access - Fairview Heights
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Phyllis D Marx
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Great Lakes Clinical Trials - Gurnee
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jeffrey S. Ross
      • Itasca, Illinois, United States, 60143
        • Not yet recruiting
        • Option Care - Chicago
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Benjamin Lumicao
      • Lombard, Illinois, United States, 60148
        • Recruiting
        • Accellacare - DuPage
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Yoko Momoyama
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Recruiting
        • Coram CVS/Specialty Infusion Services - Fort Wayne
        • Principal Investigator:
          • Steven Donis Smith
        • Contact:
          • Phone Number: 18446887036
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, PC
        • Principal Investigator:
          • Kristi Koch George
        • Contact:
          • Phone Number: 18446887036
      • Indianapolis, Indiana, United States, 46236
        • Recruiting
        • Care Access - Indianapolis
        • Principal Investigator:
          • Steven Donis Smith
        • Contact:
          • Phone Number: 18446887036
      • Indianapolis, Indiana, United States, 46227
        • Recruiting
        • Care Access - South Indianapolis
        • Principal Investigator:
          • Gigi Lefebvre
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Recruiting
        • Covenant Medical Center
        • Principal Investigator:
          • NICHOLAS GOETSCH
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • College Park Specialty Center
        • Principal Investigator:
          • Jeffrey Kaplan
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Brownsboro Hospital
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Gregory E Cooper Ph.D., M.D.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Optum Infusion - Baton Rouge
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jason Morris
      • Lake Charles, Louisiana, United States, 70601
        • Recruiting
        • Care Access - Lake Charles
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jason Morris
    • Maryland
      • Columbia, Maryland, United States, 21046
        • Not yet recruiting
        • Optum Infusion - Columbia
        • Principal Investigator:
          • Stephen Ong
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • MD Medical Research
        • Principal Investigator:
          • Stephen Ong
        • Contact:
          • Phone Number: 844-688-7036
    • Massachusetts
      • Dorchester, Massachusetts, United States, 02124
        • Recruiting
        • Care Access - Dorchester
        • Principal Investigator:
          • Chih Chao (Justin) Yang
      • Methuen, Massachusetts, United States, 01844
        • Recruiting
        • ActivMed Practices and Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Michael J. McCartney
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Paul R Solomon
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Corporation
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • David DiBenedetto
    • Michigan
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Revival Research Institute
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Abdulhassan Saad
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minneapolis Clinic of Neurology - Burnsville Office
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Rajiv Aggarwal
      • Mendota Heights, Minnesota, United States, 55120
        • Recruiting
        • Coram CVS/Specialty Infusion Services - Mendota Heights
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Sinikka Liisa Green
      • Roseville, Minnesota, United States, 55113
        • Not yet recruiting
        • Optum Infusion - Roseville
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Rajiv Aggarwal
      • Sauk Rapids, Minnesota, United States, 56379
        • Not yet recruiting
        • Option Care - St. Cloud
        • Principal Investigator:
          • Rajiv Aggarwal
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Recruiting
        • Prime Health and Wellness/SKYCRNG
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • James B. Hall, MD
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • SKY Integrative Medical Center/SKYCRNG
        • Principal Investigator:
          • Timothy Quinn
        • Contact:
          • Phone Number: 844-688-7036
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Citizens Memorial Hospital District
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Curtis P. Schreiber
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • Clinical Research Professionals
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Siddharth Kaul
      • Saint Louis, Missouri, United States, 63117
        • Recruiting
        • IMA Clinical Research - St. Louis
        • Principal Investigator:
          • Michael Reschak
        • Contact:
          • Phone Number: 844-688-7036
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Recruiting
        • Coram CVS/Specialty Infusion Services - Henderson
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Bharat R Mocherla
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Medical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Bharat R Mocherla
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Option Care - Las Vegas
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Bharat R Mocherla
    • New Jersey
      • Hoboken, New Jersey, United States, 07030
        • Recruiting
        • IMA Clinical Research Hoboken
        • Principal Investigator:
          • Samar Hameed
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • The Cognitive and Research Center of New Jersey
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Michelle Papka
      • Warren, New Jersey, United States, 07059
        • Recruiting
        • IMA Clinical Research Warren
        • Principal Investigator:
          • Samar Hameed
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Albuquerque Neuroscience Inc.
        • Principal Investigator:
          • Daniel Allen Collins
        • Contact:
          • Phone Number: 18446887036
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Neurological Associates Albany
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Richard Holub
      • Albany, New York, United States, 12205
        • Recruiting
        • IMA Clinical Research - Albany
        • Principal Investigator:
          • Anne Nafziger
      • Bronx, New York, United States, 10456
        • Recruiting
        • Prime Global Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Ruby Hussain
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Clarity Clinical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Robert Carmen Cupelo
      • Hartsdale, New York, United States, 10530
        • Recruiting
        • IMA Clinical Research - Hartsdale
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Nader Zaki
      • New York, New York, United States, 10036
        • Recruiting
        • IMA Clinical Research
        • Principal Investigator:
          • C Grace Crocket
      • Patchogue, New York, United States, 11772
        • Recruiting
        • South Shore Neurologic Associates
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Mark Gudesblatt
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
        • Principal Investigator:
          • Mark Vincent DiBuono
        • Contact:
          • Phone Number: 18446887036
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Recruiting
        • Asheville Neurology Specialists
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Matthew Engelbrecht
      • Fayetteville, North Carolina, United States, 28314
        • Recruiting
        • Care Access - Fayetteville
        • Principal Investigator:
          • Chandar Abboy
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Care Access - Greensboro
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Chandar Abboy
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Medication Management
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • James Donald Franklin
      • Kinston, North Carolina, United States, 28501
        • Recruiting
        • Care Access - Kinston
        • Principal Investigator:
          • Chandar Abboy
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Carteret Medical Group
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Mary Katherine Lawrence
      • Pineville, North Carolina, United States, 28210
        • Recruiting
        • Care Access - Charlotte
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Chandar Abboy
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Care Access - Raleigh
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Chandar Abboy
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Accellacare - Winston-Salem
        • Principal Investigator:
          • Mitchell Gareth Isaac
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • NeuroScience Research Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Ryan S Drake
      • Cincinnati, Ohio, United States, 45215
        • Recruiting
        • Wellnow Urgent Care and Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Steve Choi
      • Dayton, Ohio, United States, 45459
        • Recruiting
        • Neurology Diagnostics, Inc.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Joel Vandersluis
      • Lima, Ohio, United States, 45805
        • Recruiting
        • Care Access - Lima
        • Principal Investigator:
          • Gigi Lefebvre
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • North Star Medical Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Mark Joseph Woyshville
      • Poland, Ohio, United States, 44514
        • Recruiting
        • Care Access - Youngstown
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Sayed M. Yossef
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Central States Research
        • Principal Investigator:
          • Sarah Land
        • Contact:
          • Phone Number: 844-688-7036
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Optum Infusion - Bend
        • Principal Investigator:
          • Michael Steven Mega
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research, Medford
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Sarah Imogene Smiley
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Center for Cognitive Health
        • Principal Investigator:
          • Michael Mega
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Recruiting
        • The Clinical Trial Center, LLC
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Alan J Levin
      • Media, Pennsylvania, United States, 19063
        • Not yet recruiting
        • Suburban Research Associates
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Shivkumar S Hatti
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Care Access - Pottsville
        • Principal Investigator:
          • Glenn Freed
        • Contact:
          • Phone Number: 844-688-7036
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Recruiting
        • Care Access Research - Warwick
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Sudhir Bansal
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Care Access - Anderson
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Anne Tuggle
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Velocity Clinical Research, Anderson
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Charles Thompson
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • VitaLink Research - Columbia
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Gregory Feldman
      • Gaffney, South Carolina, United States, 29340
        • Recruiting
        • Velocity Clinical Research, Gaffney
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • David Erb
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • VitaLink Research - Greenville
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Luis de la Cruz
      • Mauldin, South Carolina, United States, 29662
        • Recruiting
        • Care Access - Mauldin
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Anne Tuggle
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • VitaLink Research - Spartanburg
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Farhan Siddiqui
      • Union, South Carolina, United States, 29379
        • Recruiting
        • VitaLink Research - Union
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Joseph Boscia
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Richard Beasley
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, P.C.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Thomas W Arnold
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
        • Principal Investigator:
          • Lora J. McGill
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Senior Adults Specialty Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jaron L Winston
      • Austin, Texas, United States, 78749
        • Recruiting
        • Texas Diabetes & Endocrinology, P.A.
        • Principal Investigator:
          • Andrea Raymond
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Gadolin Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jason Mensah
      • Brownsville, Texas, United States, 78526
        • Recruiting
        • Headlands Research - Brownsville
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Christopher Romero
      • Conroe, Texas, United States, 77304
        • Recruiting
        • Conroe Willis Medical Research
        • Principal Investigator:
          • Robert Jeremy Laningham
        • Contact:
          • Phone Number: 18446887036
      • El Paso, Texas, United States, 79912
        • Active, not recruiting
        • Advanced Neuro Research Center - ANRC
      • Georgetown, Texas, United States, 78633
        • Recruiting
        • Care Access - Georgetown
        • Principal Investigator:
          • Peta-Gay Jackson Booth
      • Houston, Texas, United States, 77054
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Paul Ernest Schulz
      • Houston, Texas, United States, 77057
        • Recruiting
        • Next Level Urgent Care
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Wilner Jeudy
      • Houston, Texas, United States, 77054
        • Recruiting
        • Optum Infusion - Houston
        • Principal Investigator:
          • Robert Jeremy Laningham
        • Contact:
          • Phone Number: 18446887036
      • Irving, Texas, United States, 75063
        • Not yet recruiting
        • Optum Infusion - Irving
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Jason Mensah
      • McAllen, Texas, United States, 78501
        • Completed
        • Family Practice Center
      • Rio Grande City, Texas, United States, 78582
        • Recruiting
        • El Faro Health and Therapeutics
        • Principal Investigator:
          • James Antonio Falcon
        • Contact:
          • Phone Number: 18446887036
      • San Angelo, Texas, United States, 76904
        • Recruiting
        • Benchmark Research - Knickerbocker
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Darrell T. Herrington
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Diagnostics Research Group
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • John R. Holcomb
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Michelle Welch
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Contact:
          • Phone Number: 18446887036
        • Principal Investigator:
          • Eduardo Dusty Luna
    • Vermont
      • Bennington, Vermont, United States, 05201-9810
        • Recruiting
        • The Memory Clinic
        • Principal Investigator:
          • Cynthia Murphy
        • Contact:
          • Phone Number: 844-688-7036
    • Virginia
      • Alexandria, Virginia, United States, 22206
        • Recruiting
        • Care Access - Alexandria
        • Principal Investigator:
          • Jason Robert Begue
        • Contact:
          • Phone Number: 18446887036
      • Chantilly, Virginia, United States, 20151
        • Recruiting
        • Option Care - Chantilly
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Richard Jackson
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates, Inc.
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Richard Jackson
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Arifulla Khan, MD
      • Spokane Valley, Washington, United States, 99212
        • Not yet recruiting
        • Coram CVS/Specialty Infusion Services - Spokane Valley
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Arifulla Khan, MD
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Universal Research Group
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • Sabrina Ann Benjamin
      • Woodinville, Washington, United States, 98072
        • Recruiting
        • Optum Infusion - Woodinville
        • Principal Investigator:
          • Arifulla Khan, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Not yet recruiting
        • Option Care - Charleston WV
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • WARD J PAINE
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • Exemplar Research
        • Contact:
          • Phone Number: 844-688-7036
        • Principal Investigator:
          • WARD J PAINE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
  • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
  • Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion Criteria:

  • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
  • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
  • History of cancer with high risk of recurrence and preventing completion of the trial.
  • History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
  • Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
  • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  • Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
  • Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.
  • Have received active immunization against amyloid beta (Aβ) in any other study.
  • Have received active immunization against Aβ in any other study.
  • Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donanemab
Donanemab administered intravenously (IV)
Drug: Donanemab
Administered intravenously
Other Names:
  • LY3002813
Placebo Comparator: Placebo
Placebo is administered intravenously
Drug: Placebo
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS)
Time Frame: Estimated Up to Week 182
Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.
Estimated Up to Week 182

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in International Shopping List Test (ISLT)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by ISLT in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Continuous Paired Associate Learning (CPAL)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by CPAL in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by iDSSTm in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Category Fluency
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by Category Fluency in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Face Name Association Test (FNAME)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by FNAME in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by BPS-O in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Cogstate Brief Battery (CBB)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by CBB in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in CDR-Sum of Boxes (CDR-SB)
Time Frame: Baseline, Up Week 32
Change from Baseline in clinical progression as measured by CDR-SB in participants with preclinical AD.
Baseline, Up Week 32
Change from Baseline in Cognitive Function Index (CFI)
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by CFI in participants with preclinical AD.
Baseline, Up to Week 182
Change from Baseline in Montreal Cognitive Assessment (MoCA) score
Time Frame: Baseline, Up to Week 182
Change from Baseline in clinical progression as measured by MoCA score in participants with preclinical AD.
Baseline, Up to Week 182
Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State
Time Frame: Baseline through Week 76
PK: Average Serum Donanemab Concentration at Steady State
Baseline through Week 76
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Time Frame: Baseline through Week 16
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Baseline through Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Estimated)

November 8, 2027

Study Completion (Estimated)

November 8, 2027

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18284
  • I5T-MC-AACM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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