A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
2 other identifiers
interventional
550
2 countries
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 alzheimer-disease
Started May 2026
Typical duration for phase_3 alzheimer-disease
53 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
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 15, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 22, 2026
May 1, 2026
3.3 years
May 15, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Baseline through Week 130
Secondary Outcomes (4)
Change from Baseline as Measured by Cognitive Function Index (CFI)
Baseline through Week 130
Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.
Baseline through Week 130
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Baseline through Week 130
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Baseline, Week 52, Week 104
Study Arms (2)
Donanemab
EXPERIMENTALDonanemab administered intravenously (IV)
Placebo
PLACEBO COMPARATORPlacebo IV
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Care Access - Huntington Beach
Huntington Beach, California, 92648, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Infectious Disease Doctors Medical Group, APC
Walnut Creek, California, 94598, United States
VIN - Aventura
Aventura, Florida, 33180, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Finlay Medical Research
Miami, Florida, 33126, United States
VIN-Andrew Lerman
Miami, Florida, 33133, United States
Indago Research & Health Center, Inc
Miami Lakes, Florida, 33016, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Charter Research - Orlando
Orlando, Florida, 32803, United States
Headlands Research Orlando
Orlando, Florida, 32803, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
K2 Medical Research - Tampa
Tampa, Florida, 33634, United States
Charter Research - The Villages
The Villages, Florida, 32162, United States
Conquest Research
Winter Park, Florida, 32789, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46254, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Revival Research Institute, LLC
Southfield, Michigan, 48075, United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
NDx Clinical Research, Inc.
Dayton, Ohio, 45459, United States
Care Access - Lima
Lima, Ohio, 45805, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Gadolin Research
Beaumont, Texas, 77702, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Universal Research Group
Tacoma, Washington, 98405, United States
SCB Research Center
Bayamón, 00961, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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
May 15, 2026
First Posted
May 22, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should 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.