A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
NCT ID: NCT05738486
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1175 participants
INTERVENTIONAL
2023-02-28
2027-05-31
Brief Summary
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Approximately 375 additional participants will be enrolled per addendum.
The study will last approximately 91 weeks and include up to 26 visits in the main study.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1400 mg Donanemab - Standard Regimen
Participants received:
* 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8.
* placebo administered IV at week 2, 6, 10, and 14.
* 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
Donanemab
Administered IV
Placebo
Administered IV
1400 mg Donanemab - Dose Skipping
Participants received:
* 700 mg donanemab administered IV at baseline.
* placebo administered IV at week 2, 4, 6, 10, and 14.
* 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
Donanemab
Administered IV
Placebo
Administered IV
1400 mg Donanemab - Titration
Participants received:
* 350 mg donanemab administered IV at baseline.
* placebo administered IV at week 2, 6, 10, and 14.
* 700 mg donanemab administered IV at week 4.
* 1050 mg of donanemab administered IV at week 8.
* 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
Donanemab
Administered IV
Placebo
Administered IV
1400 mg Donanemab - Maximum Concentration (Cmax)
Participants received:
* 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10.
* 700 mg donanemab administered IV at weeks 12 and 14.
* 1400 mg of donanemab administered IV at weeks 16, 20, and 24.
Donanemab
Administered IV
Placebo
Administered IV
Donanemab Addendum Arm 1
Participants will receive donanemab by IV infusion.
Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion.
Donanemab
Administered IV
Placebo
Administered IV
Donanemab Addendum Arm 2
Participants will receive donanemab by IV infusion.
Participants will receive dexamethasone pretreatment prior to donanemab infusion
Donanemab
Administered IV
Dexamethasone
Administered IV
Interventions
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Donanemab
Administered IV
Placebo
Administered IV
Dexamethasone
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
* Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.
Exclusion Criteria
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
* A life expectancy of \<24 months.
* Contraindication to MRI or PET scans
* Have had prior treatment with a passive anti-amyloid immunotherapy.
* Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.
Exceptions:
* non-metastatic basal- or squamous-cell skin cancer
* Stage 0 non-invasive carcinoma of the cervix
* Stage 0 non-invasive prostate cancer, or
* other cancers with low risk of recurrence or spread
60 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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MD First Research - Chandler
Chandler, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Healthy Brain Clinic
Long Beach, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
JEM Research Institute
Atlantis, Florida, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
K2 Medical Research
Clermont, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
ClinCloud - Maitland
Maitland, Florida, United States
K2 Medical Research
Maitland, Florida, United States
ClinCloud - Viera
Melbourne, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
K2 Summit Research
The Villages, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, United States
Palm Beach Neurology
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Columbus Memory Center, LLC
Columbus, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Butler Hospital
Providence, Rhode Island, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Gadolin Research
Beaumont, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Re:Cognition Health
Fairfax, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Universal Research Group
Tacoma, Washington, United States
Re:Cognition Health - Bristol
Bristol, Bristol, City of, United Kingdom
Re:Cognition Health - Winchester
Winchester, Hampshire, United Kingdom
Re:Cognition Health - London
London, London, City of, United Kingdom
Re:Cognition Health Guildford
Guildford, Reading, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, , United Kingdom
Re:Cognition Health - Plymouth
Plymouth, , United Kingdom
Countries
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References
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Wang H, Nery ESM, Ardayfio P, Khanna R, Svaldi DO, Shcherbinin S, Xu W, Andersen SW, Hauck PM, Brooks DA, Collins EC, Salloway S, Mintun MA, Sims JR. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. 2025 Sep;12(8):100266. doi: 10.1016/j.tjpad.2025.100266. Epub 2025 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Other Identifiers
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I5T-MC-AACQ
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502268-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1285-9438
Identifier Type: OTHER
Identifier Source: secondary_id
18648
Identifier Type: -
Identifier Source: org_study_id