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

RecruitingPhase 2

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

Who can join

Ages 55 to 85 · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 350 · Started: May 20, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07589595

Locations in the U.S.

ArizonaTrialSphere Corp, Chandler
HonorHealth Research Institute, Scottsdale (Not yet recruiting)
CaliforniaProfound Research LLC, Carlsbad
Irvine Clinical Research, Irvine
UCSD - Altman Clinical and Translational Research Institute (ACTRI), La Jolla (Not yet recruiting)
Stanford Neuroscience Health Center, Palo Alto (Not yet recruiting)
ColoradoCenExel Rocky Mountain Clinical Research, Englewood (Not yet recruiting)
ConnecticutKi Health Partners, LLc, dba New England Institute for Clinical Research, Stamford
FloridaJEM Research Institute, Atlantis
VIN - Aventura, Aventura
Brain Matters Research, Delray Beach
Neuropsychiatric Research Center of Southwest Florida, Fort Myers
Norman Fixel Institute for Neurological Diseases (FIND), Gainesville (Not yet recruiting)
Mayo Clinic in Florida, Jacksonville (Not yet recruiting)
K2 Medical Research ORLANDO, Maitland
BRP-Kendal Lakes, Miami
Renstar Medical Research, Ocala
Charter Research - Orlando, Orlando
Axiom Brain Health LLC, Tampa
Palm Beach Neurology, West Palm Beach
Conquest Research, Winter Park
IndianaIndiana University Health Neuroscience Center, Indianapolis
KansasThe University of Kansas - Clinical Research Center, Fairway (Not yet recruiting)
MassachusettsMassachusetts General Hospital - Charlestown, Charlestown (Not yet recruiting)
K2 Medical Research - Foxborough, Foxborough
Neurology Center of New England, Foxborough
Headlands Eastern MA LLC, Plymouth
MichiganQUEST Research Institute, Farmington Hills
MinnesotaStruthers Parkinson's Center, Golden Valley (Not yet recruiting)
Mayo Clinic in Rochester, Minnesota, Rochester (Not yet recruiting)
MissouriCitizens Memorial Hospital District, Bolivar
OregonOregon Health and Science University, Portland (Not yet recruiting)
Summit Headlands, Portland
PennsylvaniaPennsylvania Hospital, Philadelphia (Not yet recruiting)
TexasGadolin Research, Beaumont
Kerwin Medical Center, Dallas
Houston Methodist Hospital, Houston (Not yet recruiting)
The University of Texas Health Science Center at Houston, Houston
Central Texas Neurology Consultants, Round Rock
The University of Texas Health Science Center, San Antonio
VirginiaRe:Cognition Health, Fairfax
WashingtonEvergreenHealth, Kirkland (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.