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Clinical Trials in the USA / NCT07589595
Recruiting Phase 2

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

NCT07589595 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-05-20
Last updated
2026-09-08

Condition(s) studied

Cognitive DysfunctionLewy Body DiseaseSynucleinopathiesAmyloid

Investigational drug(s) / intervention(s)

DonanemabPlacebo

Donanemab: Donanemab administered IV

Placebo: Placebo administered IV

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
TrialSphere Corp Chandler Arizona Recruiting
HonorHealth Research Institute Scottsdale Arizona Not Yet Recruiting
Profound Research LLC Carlsbad California Recruiting
Irvine Clinical Research Irvine California Recruiting
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California Not Yet Recruiting
Stanford Neuroscience Health Center Palo Alto California Not Yet Recruiting
CenExel Rocky Mountain Clinical Research Englewood Colorado Not Yet Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut Not Yet Recruiting
JEM Research Institute Atlantis Florida Recruiting
VIN - Aventura Aventura Florida Recruiting
Brain Matters Research Delray Beach Florida Recruiting
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida Recruiting
Norman Fixel Institute for Neurological Diseases (FIND) Gainesville Florida Not Yet Recruiting
Mayo Clinic in Florida Jacksonville Florida Not Yet Recruiting
K2 Medical Research ORLANDO Maitland Florida Recruiting
BRP-Kendal Lakes Miami Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Charter Research - Orlando Orlando Florida Recruiting
Axiom Brain Health LLC Tampa Florida Recruiting
Palm Beach Neurology West Palm Beach Florida Recruiting
Conquest Research Winter Park Florida Recruiting
Indiana University Health Neuroscience Center Indianapolis Indiana Recruiting
The University of Kansas - Clinical Research Center Fairway Kansas Not Yet Recruiting
Massachusetts General Hospital - Charlestown Charlestown Massachusetts Not Yet Recruiting
K2 Medical Research - Foxborough Foxborough Massachusetts Recruiting
Neurology Center of New England Foxborough Massachusetts Recruiting
Headlands Eastern MA LLC Plymouth Massachusetts Recruiting
QUEST Research Institute Farmington Hills Michigan Recruiting
Struthers Parkinson's Center Golden Valley Minnesota Not Yet Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Not Yet Recruiting
Citizens Memorial Hospital District Bolivar Missouri Recruiting
Summit Headlands Portland Oregon Recruiting
Oregon Health and Science University Portland Oregon Not Yet Recruiting
Pennsylvania Hospital Philadelphia Pennsylvania Not Yet Recruiting
Gadolin Research Beaumont Texas Recruiting
Kerwin Medical Center Dallas Texas Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
The University of Texas Health Science Center at Houston Houston Texas Not Yet Recruiting
Central Texas Neurology Consultants Round Rock Texas Recruiting
The University of Texas Health Science Center San Antonio Texas Recruiting

+ 32 more sites — see the full list on the official registry below.

On this site

📄 Kisunla (donanemab) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07589595 on ClinicalTrials.gov ↗ ← All trials in the USA