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

Purpose

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.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 65 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. Addendum 7 Exclusion Criteria for Clinicaltrials.gov: - Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Donanemab 		Donanemab administered intravenously (IV)
  • Drug: Donanemab
    Administered intravenously
    Other names:
    • LY3002813
Placebo Comparator
Placebo 		Placebo is administered intravenously
  • Drug: Placebo
    Administered intravenously

Recruiting Locations

Care Access - 801 South Power Road, Mesa
Mesa, Arizona 85206
Contact:
480-801-9837

Banner Alzheimer's Institute
Phoenix, Arizona 85006
Contact:
602-839-6900

Barrow Neurological Institute
Phoenix, Arizona 85013

Banner Alzheimer's Institute Tucson
Tucson, Arizona 85718
Contact:
520-694-4124

Care Access Research - Huntington Beach
Huntington Beach, California 92648
Contact:
714-378-2440

Irvine Clinical Research
Irvine, California 92614
Contact:
949-753-1663

Healthy Brain Clinic
Long Beach, California 90804
Contact:
562-606-5999

Neurovations
Napa, California 94558
Contact:
707-252-9656

Artemis Institute for Clinical Research
Riverside, California 92503
Contact:
619-915-0496

Clinical Trials Research
Sacramento, California 95821
Contact:
916-434-8230

Artemis Institute for Clinical Research
San Diego, California 92103
Contact:
619-915-0496

Syrentis Clinical Research
Santa Ana, California 92705
Contact:
714-542-3008

Providence Medical Foundation
Santa Rosa, California 95403
Contact:
707-290-1848

Infectious Disease Doctors Medical Group, APC
Walnut Creek, California 94598
Contact:
925-947-2334

Care Access - Aurora
Aurora, Colorado 80012
Contact:
303-337-5707

Mountain Neurological Research Center
Basalt, Colorado 81621
Contact:
970-927-1141

Invicro
New Haven, Connecticut 06510
Contact:
203-401-4300

VIN-Julie Schwartzbard
Aventura, Florida 33180
Contact:
305-933-5993

Bradenton Research Center, Inc.
Bradenton, Florida 34205
Contact:
941-708-0005

Finlay Medical Research
Greenacres City, Florida 33467
Contact:
561-766-2181

Indago Research & Health Center, Inc
Hialeah, Florida 33012
Contact:
305-825-6588

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Contact:
904-730-0101

ClinCloud - Maitland
Maitland, Florida 32751

K2 Medical Research
Maitland, Florida 32751
Contact:
407-500-5252

ClinCloud - Viera
Melbourne, Florida 32940
Contact:
407-680-0534

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

Finlay Medical Research
Miami, Florida 33126

VIN-Andrew Lerman
Miami, Florida 33133
Contact:
786-655-8010

Adult Medicine of Lake County
Mount Dora, Florida 32757
Contact:
352-383-8222

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652
Contact:
727-849-4131

Charter Research - Winter Park
Orlando, Florida 32803
Contact:
407-337-1000

Headlands Research Orlando
Orlando, Florida 32819
Contact:
407-705-3471

Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida 32504
Contact:
850-438-1136

Progressive Medical Research
Port Orange, Florida 32127
Contact:
386-304-7070

Care Access - Sun City Center - Cypress Village Boulevard
Sun City Center, Florida 33573
Contact:
855-339-1116

K2 Medical Research - Tampa
Tampa, Florida 33607
Contact:
813-800-5252

Stedman Clinical Trials
Tampa, Florida 33613
Contact:
813-971-8311

Charter Research - Lady Lake
The Villages, Florida 32162
Contact:
352-441-2000

Conquest Research
Winter Park, Florida 32789
Contact:
407-916-0060

iResearch Atlanta
Decatur, Georgia 30030
Contact:
404-537-1281

Center for Advanced Research & Education
Gainesville, Georgia 30501
Contact:
770-534-5154

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

Northwest Clinical Trials
Boise, Idaho 83704
Contact:
208-685-0600

Great Lakes Clinical Trials - Andersonville
Chicago, Illinois 60640
Contact:
773-275-3500

Care Access - South Indianapolis
Indianapolis, Indiana 46227
Contact:
351-222-6663

Care Access - Indianapolis
Indianapolis, Indiana 46236
Contact:
269-263-2405

Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana 46256
Contact:
317-537-6099

Covenant Medical Center
Waterloo, Iowa 50702
Contact:
319-272-2112

Norton Brownsboro Hospital
Louisville, Kentucky 40241
Contact:
502-394-6460

Care Access - Lake Charles
Lake Charles, Louisiana 70601
Contact:
337-602-6642

Boston Center for Memory
Newton, Massachusetts 02459
Contact:
617-699-6927

Care Access - Quincy
Quincy, Massachusetts 02169
Contact:
650-796-1586

MedVadis Research Corporation
Waltham, Massachusetts 02451
Contact:
617-744-1310

Revival Research Institute
Southfield, Michigan 48075
Contact:
586-276-7453

Citizens Memorial Hospital District
Bolivar, Missouri 65613
Contact:
417-328-7781

Las Vegas Medical Research
Las Vegas, Nevada 89128
Contact:
702-750-000

The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
Contact:
973-850-4622

Care Access - Charlotte
Charlotte, North Carolina 28210
Contact:
351-222-5383

Monroe Biomedical Research
Monroe, North Carolina 28112
Contact:
704-283-7359

Carteret Medical Group
Morehead City, North Carolina 28557
Contact:
252-499-8623

Neurology Diagnostics, Inc.
Dayton, Ohio 45459
Contact:
937-224-8200

Care Access - Lima
Lima, Ohio 45805
Contact:
351-222-6663

VitaLink Research - Greenville
Greenville, South Carolina 29615
Contact:
864-770-0890

VitaLink Research - Spartanburg
Spartanburg, South Carolina 29303
Contact:
864-515-0092

Senior Adults Specialty Research
Austin, Texas 78757
Contact:
512-407-8628

Gadolin Research
Beaumont, Texas 77702
Contact:
409-331-6040

Care Access - Georgetown
Georgetown, Texas 78633
Contact:
351-222-4915

The University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
713-486-0536

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

The Memory Clinic
Bennington, Vermont 05201-9810
Contact:
413-281-0576

Northwest Clinical Research Center
Bellevue, Washington 98007
Contact:
425-453-0404

Universal Research Group
Tacoma, Washington 98405
Contact:
253-882-1070

SCB Research Center
Bayamon, Puerto Rico 00961
Contact:
(787) 798-4592

More Details

NCT ID
NCT05026866
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center