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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Sponsor: Eli Lilly and Company
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.
Official title: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1175
Start Date
2023-02-28
Completion Date
2027-05
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
Donanemab
Administered IV
Placebo
Administered IV
Dexamethasone
Administered IV
Locations (49)
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