A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Recruiting · NCT07589595 · 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 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.
Who can take part
Age range
55 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
- Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
- Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
- Meet plasma P-tau217 criteria.
- Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
- Have a CSF result consistent with the presence of alpha-synuclein pathology.
- Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Exclusion criteria
- Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
- Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
- Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
- Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
- Have previously received amyloid-targeting therapy.
- Active immunization against amyloid-beta.
- Have a centrally read MRI that does not meet study entry criteria.
- Have contraindication to MRI or PET scans.
- Have any contraindication to lumbar puncture.
Where it is running
60 locations listed across 16 US states.
- 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
- K2 Medical Research - Foxborough - Foxborough, 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
- 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
- Gangnam Severance Hospital, Yonsei University Health System - Gangnam-gu, South Korea
- Hyogo Prefectural Harima-Himeji General Medical Center - Himeji, Japan
- Inage Neurology and Memory Clinic - Inage, Japan
- Inha University Hospital - Incheon, South Korea
- Nippon Medical School Musashi Kosugi Hospital - Kawasaki, Japan
- St. Marianna University Hospital - Kawasaki, Japan
- Kobe University Hospital - Kobe, Japan
- Katayama Medical Clinic - Kurashiki, Japan
- Juntendo Tokyo Koto Geriatric Medical Center - Kōtoku, Japan
- Nagoya Ekisaikai Hospital - Nagoya, Japan
- Nagoya University Hospital - Nagoya, Japan
- Gachon University Gil Medical Center - Namdong-gu, South Korea
- Taipei Medical University Shuang Ho Hospital - New Taipei City, Taiwan
- New Taipei Municipal TuCheng Hospital - New Taipei City, Taiwan
- Hanyang University Seoul Hospital - Seoul, South Korea
- Konkuk University Medical Center - Seoul, South Korea
Showing 60 of 72 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →