A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
4 other identifiers
interventional
1,175
2 countries
49
Brief Summary
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2023
Typical duration for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2024
CompletedResults Posted
Study results publicly available
November 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedNovember 14, 2025
October 1, 2025
1.2 years
February 13, 2023
May 16, 2025
October 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
24 Weeks
Secondary Outcomes (7)
Percentage of Participants With Any Occurrence of ARIA-E
52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Baseline, 76 Weeks
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
24 Weeks
Percentage of Participants With ARIA-H
52 Weeks
Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H
76 Weeks
- +2 more secondary outcomes
Study Arms (6)
1400 mg Donanemab - Standard Regimen
EXPERIMENTALParticipants 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.
1400 mg Donanemab - Dose Skipping
EXPERIMENTALParticipants 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.
1400 mg Donanemab - Titration
EXPERIMENTALParticipants 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.
1400 mg Donanemab - Maximum Concentration (Cmax)
EXPERIMENTALParticipants 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 Addendum Arm 1
EXPERIMENTALParticipants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion.
Donanemab Addendum Arm 2
EXPERIMENTALParticipants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion
Interventions
Administered IV
Administered IV
Eligibility Criteria
You may qualify if:
- Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
- 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.
You may not qualify if:
- Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
MD First Research - Chandler
Chandler, Arizona, 85286, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
K2 Medical Research
Clermont, Florida, 34711, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
ClinCloud - Maitland
Maitland, Florida, 32751, United States
K2 Medical Research
Maitland, Florida, 32751, United States
ClinCloud - Viera
Melbourne, Florida, 32940, 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
Progressive Medical Research
Port Orange, Florida, 32127, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997, United States
K2 Medical Research - Tampa
Tampa, Florida, 33607, United States
K2 Summit Research
The Villages, Florida, 32159, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
Columbus Memory Center, LLC
Columbus, Georgia, 31909, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Neurology Clinic, P.C.
Cordova, Tennessee, 38018, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Re:Cognition Health - Bristol
Bristol, Bristol, City of, BS32 4SY, United Kingdom
Re:Cognition Health - Winchester
Winchester, Hampshire, SO21 1HU, United Kingdom
Re:Cognition Health - London
London, London, City of, W1G 9JF, United Kingdom
Re:Cognition Health Guildford
Guildford, Reading, GU2 7YD, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, B16 8LT, United Kingdom
Re:Cognition Health - Plymouth
Plymouth, PL6 8BT, United Kingdom
Related Publications (1)
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.
PMID: 40619285DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
February 28, 2023
Primary Completion
May 16, 2024
Study Completion (Estimated)
May 1, 2027
Last Updated
November 14, 2025
Results First Posted
November 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.