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

NCT ID: NCT07589595
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Conditions: Amyloid, Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 350 participants (Estimated).

What is being studied

Intervention: donanemab
Drug: Donanemab
Drug: Placebo

Who may be eligible

Ages: 55 Years to 85 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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 locations

72 study locations are listed.

Recruiting site status is explicitly provided for 72 locations; 37 are listed as Recruiting.

Countries: Japan, South Korea, Taiwan, United States

Arizona, United States: 2
California, United States: 4
Colorado, United States: 1
Connecticut, United States: 1
Florida, United States: 13
Indiana, United States: 1
Kansas, United States: 1
Massachusetts, United States: 4
Michigan, United States: 1
Minnesota, United States: 2
Missouri, United States: 1
Oregon, United States: 2
Pennsylvania, United States: 1
Texas, United States: 6
Virginia, United States: 1
Washington, United States: 1

Sample of listed locations

Memory Clinic Ochanomizu — Bunkyō City, 113-0034, Japan — Recruiting
Hyogo Prefectural Harima-Himeji General Medical Center — Himeji, 670-8560, Japan — Recruiting
Inage Neurology and Memory Clinic — Inage, 263-0043, Japan — Recruiting
Kobe University Hospital — Kobe, 650-0017, Japan — Recruiting
Katayama Medical Clinic — Kurashiki, 710-0813, Japan — Recruiting
Nagoya Ekisaikai Hospital — Nagoya, 454-8502, Japan — Recruiting
National Center for Geriatrics and Gerontology — Ōbu, 474-8511, Japan — Recruiting
Tachikawa Hospital — Tachikawa, 190-8531, Japan — Recruiting
Memory Clinic Toride — Toride, 302-0004, Japan — Recruiting
TrialSphere Corp — Chandler, Arizona, 85286, United States — Recruiting
Profound Research LLC — Carlsbad, California, 92011, United States — Recruiting
Irvine Clinical Research — Irvine, California, 92614, United States — Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, 06905, United States — Recruiting
JEM Research Institute — Atlantis, Florida, 33462, United States — Recruiting
VIN - Aventura — Aventura, Florida, 33180, United States — Recruiting
Brain Matters Research — Delray Beach, Florida, 33445, United States — Recruiting
Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, 33912, United States — Recruiting
K2 Medical Research ORLANDO — Maitland, Florida, 32751, United States — Recruiting
BRP-Kendal Lakes — Miami, Florida, 33175, United States — Recruiting
Renstar Medical Research — Ocala, Florida, 34471, United States — Recruiting
Charter Research - Orlando — Orlando, Florida, 32803, United States — Recruiting
Axiom Brain Health LLC — Tampa, Florida, 33609, United States — Recruiting
Palm Beach Neurology — West Palm Beach, Florida, 33407, United States — Recruiting
Conquest Research — Winter Park, Florida, 32789, United States — Recruiting
Indiana University Health Neuroscience Center — Indianapolis, Indiana, 46202, United States — Recruiting

Study details

Start date: May 20, 2026
Primary completion date: August 1, 2028
Completion date: August 1, 2028
First posted: May 15, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07589595
Registry last updated: September 22, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07589595 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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