RECRUITING

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

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Conditions

Alzheimer Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD). Approximately 800 additional participants will be enrolled in a 12-month addendum to assess safety of a different titration regimen.

Official Title

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

Quick Facts

Study Start:2021-08-27
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05026866

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.

Ages Eligible for Study:65 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
  2. * Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
  3. * Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  4. * Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
  5. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  6. * 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.
  1. * Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
  2. * 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.
  3. * History of cancer with high risk of recurrence and preventing completion of the trial.
  4. * 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).
  5. * 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.
  6. * Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  7. * 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.
  8. * Have had prior treatment with a passive anti-amyloid immunotherapy \<5 half-lives prior to randomization.
  9. * Have received active immunization against amyloid beta (Aβ) in any other study.
  10. * Have received active immunization against Aβ in any other study.
  11. * Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.
  12. * Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
lilly_clinical_trials@lilly.com

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Parkway Medical Center
Birmingham, Alabama, 35215
United States
Alabama Psychiatry - Birmingham - Brookwood Medical Center Drive
Homewood, Alabama, 35209
United States
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805
United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206
United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
United States
Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
Care Access - Berkeley
Berkeley, California, 94705
United States
Care Access - Beverly Hills
Beverly Hills, California, 90212
United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
United States
Valley Clinical Trials, Inc.
Covina, California, 91723
United States
Neurology Center of North Orange County
Fullerton, California, 92835
United States
Care Access - Gilroy
Gilroy, California, 95020
United States
Care Access Research - Huntington Beach
Huntington Beach, California, 92648
United States
Irvine Clinical Research
Irvine, California, 92614
United States
Option Care - Irvine
Irvine, California, 92618
United States
Kaizen Brain Center
La Jolla, California, 92037
United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942
United States
Pacific Research Network
Lemon Grove, California, 91945
United States
Healthy Brain Clinic
Long Beach, California, 90804
United States
Neurovations
Napa, California, 94558
United States
Care Access - Newport Beach
Newport Beach, California, 92660
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Inland Psychiatric Medical Group
Redlands, California, 92373
United States
Anderson Clinical Research
Redlands, California, 92374
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Option Care - Riverside
Riverside, California, 92507
United States
Option Care - Sacramento
Sacramento, California, 95816
United States
Clinical Trials Research
Sacramento, California, 95821
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
Ray Dolby Brain Health Center
San Francisco, California, 94114
United States
Care Access - Los Gatos
San Jose, California, 95124
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Care Access - Santa Clarita
Santa Clarita, California, 91321
United States
Option Care - Los Angeles South
Santa Fe Springs, California, 90670
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
Mazur, Statner, Dutta, Nathan, PC
Thousand Oaks, California, 91360
United States
Tilda Research
Tustin, California, 92780
United States
Velocity Clinical Research, Panorama City
Van Nuys, California, 91405
United States
Infectious Disease Doctors Medical Group, APC
Walnut Creek, California, 94598
United States
Care Access - Aurora
Aurora, Colorado, 80012
United States
Mountain Neurological Research Center
Basalt, Colorado, 81621
United States
Denver Neurological Research
Denver, Colorado, 80210
United States
Invicro
New Haven, Connecticut, 06510
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180
United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
SFM Clinical Research
Boca Raton, Florida, 33487
United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
United States
Care Access - Daytona Beach
Daytona Beach, Florida, 32114
United States
Care Access - Delray Beach
Delray Beach, Florida, 33484
United States
Finlay Medical Research
Greenacres City, Florida, 33467
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Coram CVS/Specialty Infusion Services - Jacksonville
Jacksonville, Florida, 32256
United States
Care Access - Guava Street
Lady Lake, Florida, 32159
United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, 33777
United States
ClinCloud - Maitland
Maitland, Florida, 32751
United States
K2 Medical Research
Maitland, Florida, 32751
United States
ClinCloud - Viera
Melbourne, Florida, 32940
United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
United States
South Florida Research Phase I-IV
Miami Springs, Florida, 33166
United States
Optimus U Corporation
Miami, Florida, 33125
United States
Finlay Medical Research
Miami, Florida, 33126
United States
VIN-Andrew Lerman
Miami, Florida, 33133
United States
IMIC, Inc.
Miami, Florida, 33176
United States
The Neurology Research Group
Miami, Florida, 33176
United States
VIN-Victor Faradji
Miami, Florida, 33176
United States
Adult Medicine of Lake County
Mount Dora, Florida, 32757
United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Charter Research - Winter Park
Orlando, Florida, 32803
United States
Headlands Research Orlando
Orlando, Florida, 32819
United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33024
United States
VIN- Margarita Almeida El-Ramey
Pembroke Pines, Florida, 33026
United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Care Access - Pebble Beach Boulevard, Tampa
Sun City, Florida, 33573
United States
Care Access - Tamarac
Tamarac, Florida, 33321
United States
Clinical Research of West Florida
Tampa, Florida, 33606
United States
K2 Medical Research - Tampa
Tampa, Florida, 33607
United States
Stedman Clinical Trials
Tampa, Florida, 33613
United States
Vicis Clinical Research
Tampa, Florida, 33615
United States
Coram CVS/Specialty Infusion Services - Tampa
Tampa, Florida, 33634
United States
Charter Research - Lady Lake
The Villages, Florida, 32162
United States
Palm Beach Research Center
West Palm Beach, Florida, 33409
United States
Conquest Research
Winter Park, Florida, 32789
United States
Masters of Clinical Research
Augusta, Georgia, 30909
United States
iResearch Atlanta
Decatur, Georgia, 30030
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
SKY Clinical Research Network Group-Blake
Union City, Georgia, 30291
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Northwest Clinical Trials
Boise, Idaho, 83704
United States
IMA Clinical Research - Chicago
Chicago, Illinois, 60602
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
United States
Uptown Research Institute
Chicago, Illinois, 60640
United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, 60007
United States
Care Access - Fairview Heights
Fairview Heights, Illinois, 62208
United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60031
United States
Option Care - Chicago
Itasca, Illinois, 60143
United States
Accellacare - DuPage
Lombard, Illinois, 60148
United States
Coram CVS/Specialty Infusion Services - Fort Wayne
Fort Wayne, Indiana, 46805
United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46227
United States
Care Access - Indianapolis
Indianapolis, Indiana, 46236
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
United States
Covenant Medical Center
Waterloo, Iowa, 50702
United States
College Park Specialty Center
Overland Park, Kansas, 66212
United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
United States
Optum Infusion - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Care Access - Lake Charles
Lake Charles, Louisiana, 70601
United States
Optum Infusion - Columbia
Columbia, Maryland, 21046
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Care Access - Dorchester
Dorchester, Massachusetts, 02124
United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844
United States
Boston Center for Memory
Newton, Massachusetts, 02459
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Revival Research Institute
Southfield, Michigan, 48075
United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337
United States
Coram CVS/Specialty Infusion Services - Mendota Heights
Mendota Heights, Minnesota, 55120
United States
Optum Infusion - Roseville
Roseville, Minnesota, 55113
United States
Option Care - St. Cloud
Sauk Rapids, Minnesota, 56379
United States
SKY Clinical Research Network Group - Hall
Fayette, Mississippi, 39069
United States
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi, 39157
United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
IMA Clinical Research - St. Louis
Saint Louis, Missouri, 63117
United States
Coram CVS/Specialty Infusion Services - Henderson
Henderson, Nevada, 89014
United States
Option Care - Las Vegas
Las Vegas, Nevada, 89102
United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128
United States
IMA Clinical Research Hoboken
Hoboken, New Jersey, 07030
United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
United States
IMA Clinical Research Warren
Warren, New Jersey, 07059
United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
United States
IMA Clinical Research Albany
Albany, New York, 12205
United States
Neurological Associates Albany
Albany, New York, 12208
United States
Prime Global Research
Bronx, New York, 10456
United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
United States
IMA Clinical Research Westchester
Hartsdale, New York, 10530
United States
IMA Clinical Research
New York, New York, 10036
United States
South Shore Neurologic Associates
Patchogue, New York, 11772
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Asheville Neurology Specialists
Asheville, North Carolina, 28806
United States
Care Access - Charlotte
Charlotte, North Carolina, 28210
United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314
United States
Care Access - Greensboro
Greensboro, North Carolina, 27401
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Care Access - Kinston
Kinston, North Carolina, 28501
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Carteret Medical Group
Morehead City, North Carolina, 28557
United States
Care Access - Raleigh
Raleigh, North Carolina, 27607
United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103
United States
NeuroScience Research Center
Canton, Ohio, 44718
United States
Wellnow Urgent Care and Research
Cincinnati, Ohio, 45215
United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459
United States
Care Access - Lima
Lima, Ohio, 45805
United States
North Star Medical Research
Middleburg Heights, Ohio, 44130
United States
Care Access - Youngstown
Poland, Ohio, 44514
United States
Central States Research
Tulsa, Oklahoma, 74136
United States
Optum Infusion - Bend
Bend, Oregon, 97701
United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504
United States
Center for Cognitive Health
Portland, Oregon, 97225
United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
United States
Suburban Research Associates
Media, Pennsylvania, 19063
United States
Care Access - Pottsville
Pottsville, Pennsylvania, 17901
United States
Care Access Research - Warwick
Warwick, Rhode Island, 02886
United States
Care Access - Anderson
Anderson, South Carolina, 29621
United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
United States
VitaLink Research - Columbia
Columbia, South Carolina, 29204
United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
United States
VitaLink Research - Greenville
Greenville, South Carolina, 29615
United States
Care Access - Mauldin
Mauldin, South Carolina, 29662
United States
VitaLink Research - Spartanburg
Spartanburg, South Carolina, 29303
United States
VitaLink Research - Union
Union, South Carolina, 29379
United States
Health Concepts
Rapid City, South Dakota, 57702
United States
Neurology Clinic
Cordova, Tennessee, 38018
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119
United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
United States
Senior Adults Specialty Research
Austin, Texas, 78757
United States
Gadolin Research
Beaumont, Texas, 77702
United States
Headlands Research - Brownsville
Brownsville, Texas, 78526
United States
Conroe Willis Medical Research
Conroe, Texas, 77304
United States
Advanced Neuro Research Center - ANRC
El Paso, Texas, 79912
United States
Care Access - Georgetown
Georgetown, Texas, 78633
United States
Optum Infusion - Houston
Houston, Texas, 77054
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
United States
Next Level Urgent Care
Houston, Texas, 77057
United States
Optum Infusion - Irving
Irving, Texas, 75063
United States
Family Practice Center
McAllen, Texas, 78501
United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582
United States
Benchmark Research - Knickerbocker
San Angelo, Texas, 76904
United States
Diagnostics Research Group
San Antonio, Texas, 78229
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
The Memory Clinic
Bennington, Vermont, 05201-9810
United States
Care Access - Arlington
Arlington, Virginia, 22206
United States
Option Care - Chantilly
Chantilly, Virginia, 20151
United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Coram CVS/Specialty Infusion Services - Spokane Valley
Spokane Valley, Washington, 99212
United States
Universal Research Group
Tacoma, Washington, 98405
United States
Optum Infusion - Woodinville
Woodinville, Washington, 98072
United States
Exemplar Research
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

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 Registration Dates

Study Start Date2021-08-27
Study Completion Date2027-11

Study Record Updates

Study Start Date2021-08-27
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease