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A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

NCT07602582 · Eli Lilly and Company
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Official title
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
About this study
The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.
Eligibility criteria
Inclusion Criteria: * Have completed study AACM Addendum 7. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study. * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. * Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution. * Contraindication to florbetapir F 18 PET. * Have had history of amyloid-targeting therapy treatment outside donanemab trials. * Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.
Study design
Enrollment target: 550 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2029-09
Last updated: 2026-07-07
Interventions
Drug: DonanemabDrug: Placebo
Primary outcomes
  • Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) (Baseline through Week 130)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (59)
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Bradenton, Florida, United States
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Greenacres City, Florida, United States
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Jacksonville, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Adult Medicine of Lake County, Inc.Recruiting
Mt. Dora, Florida, United States
Suncoast Clinical Research, Inc.Recruiting
New Port Richey, Florida, United States
Charter Research - OrlandoRecruiting
Orlando, Florida, United States
Headlands Research OrlandoRecruiting
Orlando, Florida, United States
Emerald Coast Neurology - Airport BoulevardRecruiting
Pensacola, Florida, United States
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Port Orange, Florida, United States
Care Access - TampaRecruiting
Tampa, Florida, United States
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The Villages, Florida, United States
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Gainesville, Georgia, United States
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Woodstock, Georgia, United States
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Boise, Idaho, United States
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Indianapolis, Indiana, United States
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Boston Center for MemoryRecruiting
Newton, Massachusetts, United States
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Waltham, Massachusetts, United States
Revival Research Institute, LLCNot Yet Recruiting
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Citizens Memorial Hospital DistrictRecruiting
Bolivar, Missouri, United States
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Las Vegas, Nevada, United States
The Cognitive and Research Center of New JerseyRecruiting
Springfield, New Jersey, United States
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Lima, Ohio, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
The University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States
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Shavano Park, Texas, United States
Northwest Clinical Research CenterRecruiting
Bellevue, Washington, United States
Universal Research GroupRecruiting
Tacoma, Washington, United States
Tokyo-Eki Center-building ClinicNot Yet Recruiting
Chūōku, Japan
P-One ClinicNot Yet Recruiting
Hachiōji, Japan
National Center for Geriatrics and GerontologyNot Yet Recruiting
Ōbu, Japan
Samoncho ClinicNot Yet Recruiting
Shinjuku, Japan
Yotsuya Internal Medicine ClinicNot Yet Recruiting
Shinjyuku, Japan
Tokyo Metropolitan Institute for Geriatrics and GerontologyNot Yet Recruiting
tabashi City, Japan
SCB Research CenterNot Yet Recruiting
Bayamón, Puerto Rico
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). · TrialPath