A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
Recruiting · NCT07602582 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
DonanemabPlacebo
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
59 locations listed across 18 US states.
- Banner Alzheimer's Institute - Phoenix, Arizona, United States
- Care Access - Huntington Beach - Huntington Beach, California, United States
- Irvine Clinical Research - Irvine, California, United States
- Healthy Brain Clinic - Long Beach, California, United States
- Artemis Institute for Clinical Research - Riverside, California, United States
- Clinical Trials Research - Sacramento, California, United States
- Artemis Institute for Clinical Research - San Diego, California, United States
- Syrentis Clinical Research - Santa Ana, California, United States
- Providence Medical Foundation - Santa Rosa, California, United States
- Infectious Disease Doctors Medical Group, APC - Walnut Creek, California, United States
- VIN - Aventura - Aventura, Florida, United States
- Bradenton Research Center, Inc. - Bradenton, Florida, United States
- Finlay Medical Research - Greenacres City, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- K2 Medical Research ORLANDO - Maitland, Florida, United States
- Merritt Island Medical Research, LLC - Merritt Island, Florida, United States
- Finlay Medical Research - Miami, Florida, United States
- VIN-Andrew Lerman - Miami, Florida, United States
- Indago Research & Health Center, Inc - Miami Lakes, Florida, United States
- Adult Medicine of Lake County, Inc. - Mt. Dora, Florida, United States
- Suncoast Clinical Research, Inc. - New Port Richey, Florida, United States
- Charter Research - Orlando - Orlando, Florida, United States
- Headlands Research Orlando - Orlando, Florida, United States
- Emerald Coast Neurology - Airport Boulevard - Pensacola, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Care Access - Tampa - Tampa, Florida, United States
- K2 Medical Research - Tampa - Tampa, Florida, United States
- Charter Research - The Villages - The Villages, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- Center for Advanced Research & Education - Gainesville, Georgia, United States
- North Georgia Clinical Research - Woodstock, Georgia, United States
- Northwest Clinical Trials - Boise, Idaho, United States
- Great Lakes Clinical Trials - Andersonville - Chicago, Illinois, United States
- Care Access - South Indianapolis - Indianapolis, Indiana, United States
- Josephson Wallack Munshower Neurology, PC - Indianapolis, Indiana, United States
- Covenant Medical Center - Waterloo, Iowa, United States
- Care Access - Lake Charles (Bayou Pines) - Lake Charles, Louisiana, United States
- Boston Center for Memory - Newton, Massachusetts, United States
- MedVadis Research Corporation - Waltham, Massachusetts, United States
- Revival Research Institute, LLC - Southfield, Michigan, United States
- Citizens Memorial Hospital District - Bolivar, Missouri, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- The Cognitive and Research Center of New Jersey - Springfield, New Jersey, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- NDx Clinical Research, Inc. - Dayton, Ohio, United States
- Care Access - Lima - Lima, Ohio, United States
- Senior Adults Specialty Research - Austin, Texas, United States
- Gadolin Research - Beaumont, Texas, United States
- The University of Texas Health Science Center at Houston - Houston, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Universal Research Group - Tacoma, Washington, United States
- SCB Research Center - Bayamón, Puerto Rico
- Tokyo-Eki Center-building Clinic - Chūōku, Japan
- P-One Clinic - Hachiōji, Japan
- Samoncho Clinic - Shinjuku, Japan
- Yotsuya Internal Medicine Clinic - Shinjyuku, Japan
- Tokyo Metropolitan Institute for Geriatrics and Gerontology - tabashi City, Japan
- National Center for Geriatrics and Gerontology - Ōbu, Japan