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A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

NCT07589595 · Eli Lilly and Company
In plain English

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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
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-05-20
Estimated completion: 2028-08
Last updated: 2026-07-17
Interventions
Drug: DonanemabDrug: Placebo
Primary outcomes
  • Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) (Baseline through Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (72)
TrialSphere CorpRecruiting
Chandler, Arizona, United States
HonorHealth Research InstituteNot Yet Recruiting
Scottsdale, Arizona, United States
Profound Research LLCNot Yet Recruiting
Carlsbad, California, United States
Irvine Clinical ResearchRecruiting
Irvine, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)Not Yet Recruiting
La Jolla, California, United States
Stanford Neuroscience Health CenterNot Yet Recruiting
Palo Alto, California, United States
CenExel Rocky Mountain Clinical ResearchNot Yet Recruiting
Englewood, Colorado, United States
Ki Health Partners, LLc, dba New England Institute for Clinical ResearchNot Yet Recruiting
Stamford, Connecticut, United States
JEM Research InstituteRecruiting
Atlantis, Florida, United States
VIN - AventuraRecruiting
Aventura, Florida, United States
Brain Matters ResearchRecruiting
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest FloridaRecruiting
Fort Myers, Florida, United States
Norman Fixel Institute for Neurological Diseases (FIND)Not Yet Recruiting
Gainesville, Florida, United States
Mayo Clinic in FloridaNot Yet Recruiting
Jacksonville, Florida, United States
K2 Medical Research ORLANDORecruiting
Maitland, Florida, United States
BRP-Kendal LakesNot Yet Recruiting
Miami, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
Charter Research - OrlandoRecruiting
Orlando, Florida, United States
Axiom Brain Health LLCNot Yet Recruiting
Tampa, Florida, United States
Palm Beach NeurologyRecruiting
West Palm Beach, Florida, United States
Conquest ResearchRecruiting
Winter Park, Florida, United States
Indiana University Health Neuroscience CenterNot Yet Recruiting
Indianapolis, Indiana, United States
The University of Kansas - Clinical Research CenterNot Yet Recruiting
Fairway, Kansas, United States
Massachusetts General Hospital - CharlestownNot Yet Recruiting
Charlestown, Massachusetts, United States
K2 Medical Research - FoxboroughNot Yet Recruiting
Foxborough, Massachusetts, United States
Neurology Center of New EnglandNot Yet Recruiting
Foxborough, Massachusetts, United States
Headlands Eastern MA LLCNot Yet Recruiting
Plymouth, Massachusetts, United States
QUEST Research InstituteRecruiting
Farmington Hills, Michigan, United States
Struthers Parkinson's CenterNot Yet Recruiting
Golden Valley, Minnesota, United States
Mayo Clinic in Rochester, MinnesotaNot Yet Recruiting
Rochester, Minnesota, United States
Citizens Memorial Hospital DistrictRecruiting
Bolivar, Missouri, United States
Summit HeadlandsRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityNot Yet Recruiting
Portland, Oregon, United States
Pennsylvania HospitalNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Gadolin ResearchNot Yet Recruiting
Beaumont, Texas, United States
Kerwin Medical CenterRecruiting
Dallas, Texas, United States
Houston Methodist HospitalNot Yet Recruiting
Houston, Texas, United States
The University of Texas Health Science Center at HoustonNot Yet Recruiting
Houston, Texas, United States
Central Texas Neurology ConsultantsRecruiting
Round Rock, Texas, United States
The University of Texas Health Science CenterNot Yet Recruiting
San Antonio, Texas, United States
Re:Cognition HealthRecruiting
Fairfax, Virginia, United States
EvergreenHealthNot Yet Recruiting
Kirkland, Washington, United States
Memory Clinic OchanomizuNot Yet Recruiting
Bunkyō City, Japan
Shonan Keiiku HospitalNot Yet Recruiting
Fujisawa, Japan
Hyogo Prefectural Harima-Himeji General Medical CenterNot Yet Recruiting
Himeji, Japan
Inage Neurology and Memory ClinicNot Yet Recruiting
Inage, Japan
Nippon Medical School Musashi Kosugi HospitalNot Yet Recruiting
Kawasaki, Japan
St. Marianna University HospitalNot Yet Recruiting
Kawasaki, Japan
Kobe University HospitalNot Yet Recruiting
Kobe, Japan
Juntendo Tokyo Koto Geriatric Medical CenterNot Yet Recruiting
Kōtoku, Japan
Katayama Medical ClinicNot Yet Recruiting
Kurashiki, Japan
Nagoya Ekisaikai HospitalNot Yet Recruiting
Nagoya, Japan
Nagoya University HospitalNot Yet Recruiting
Nagoya, Japan
National Center for Geriatrics and GerontologyNot Yet Recruiting
Ōbu, Japan
The University of Osaka HospitalNot Yet Recruiting
Suita, Japan
Tokyo Metropolitan Institute for Geriatrics and GerontologyNot Yet Recruiting
tabashi City, Japan
Tachikawa HospitalNot Yet Recruiting
Tachikawa, Japan
Memory Clinic TorideNot Yet Recruiting
Toride, Japan
Yokohama Minami Kyosai HospitalNot Yet Recruiting
Yokohama, Japan
Oita University HospitalNot Yet Recruiting
Yufu, Japan
Gangnam Severance Hospital, Yonsei University Health SystemNot Yet Recruiting
Gangnam-gu, South Korea
Inha University HospitalNot Yet Recruiting
Incheon, South Korea
Severance Hospital, Yonsei University Health SystemNot Yet Recruiting
Seoul, South Korea
Hanyang University Seoul HospitalNot Yet Recruiting
Seoul, South Korea
Konkuk University Medical CenterNot Yet Recruiting
Seoul, South Korea
Ewha Womans University Mokdong HospitalNot Yet Recruiting
Seoul, South Korea
Taipei Medical University Shuang Ho HospitalNot Yet Recruiting
New Taipei City, Taiwan
New Taipei Municipal TuCheng HospitalNot Yet Recruiting
New Taipei City, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchNot Yet Recruiting
Taoyuan, Taiwan
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) · TrialPath