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A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Official title: A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2026-05
Completion Date
2028-08
Last Updated
2026-05-15
Healthy Volunteers
No
Interventions
Donanemab
Donanemab administered IV
Placebo
Placebo administered IV
Locations (70)
TrialSphere Corp
Chandler, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Profound Research LLC
Carlsbad, California, United States
Irvine Clinical Research
Irvine, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
VIN - Aventura
Aventura, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Norman Fixel Institute for Neurological Diseases (FIND)
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
K2 Medical Research ORLANDO
Maitland, Florida, United States
BRP-Kendal Lakes
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
Axiom Brain Health LLC
Tampa, Florida, United States
Palm Beach Neurology
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, United States
Massachusetts General Hospital - Charlestown
Charlestown, Massachusetts, United States
Neurology Center of New England
Foxborough, Massachusetts, United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Citizens Memorial Hospital District
Bolivar, Missouri, United States
Summit Headlands
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
K2 Medical Research - East Providence
East Providence, Rhode Island, United States
Gadolin Research
Beaumont, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
The University of Texas Health Science Center
San Antonio, Texas, United States
Re:Cognition Health
Fairfax, Virginia, United States
EvergreenHealth
Kirkland, Washington, United States
Memory Clinic Ochanomizu
Bunkyō City, Japan
Shonan Keiiku Hospital
Fujisawa, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Japan
Inage Neurology and Memory Clinic
Inage, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, Japan
St. Marianna University Hospital
Kawasaki, Japan
Kobe University Hospital
Kobe, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Kōtoku, Japan
Katayama Medical Clinic
Kurashiki, Japan
Nagoya University Hospital
Nagoya, Japan
National Center for Geriatrics and Gerontology
Ōbu, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
tabashi City, Japan
Tachikawa Hospital
Tachikawa, Japan
Memory Clinic Toride
Toride, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Japan
Oita University Hospital
Yufu, Japan
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, South Korea
Inha University Hospital
Incheon, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan