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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid

In brief

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.

Key facts

Study ID

NCT07589595

Run by

Eli Lilly and Company

People needed

350

Starts

2026-05-20

Expected to finish

2028-08-01

Last updated by the study team

2026-08-06

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Summit Headlands — Portland, Oregon, United States (enrolling)
• Katayama Medical Clinic — Kurashiki, Japan (enrolling)
• QUEST Research Institute — Farmington Hills, Michigan, United States (enrolling)
• Citizens Memorial Hospital District — Bolivar, Missouri, United States (enrolling)
• Kerwin Medical Center — Dallas, Texas, United States (enrolling)
• Re:Cognition Health — Fairfax, Virginia, United States (enrolling)
• Headlands Eastern MA LLC — Plymouth, Massachusetts, United States (enrolling)
• JEM Research Institute — Atlantis, Florida, United States (enrolling)
• VIN - Aventura — Aventura, Florida, United States (enrolling)
• TrialSphere Corp — Chandler, Arizona, United States (enrolling)
• Gadolin Research — Beaumont, Texas, United States (enrolling)
• Profound Research LLC — Carlsbad, California, United States (enrolling)
• Central Texas Neurology Consultants — Round Rock, Texas, United States (enrolling)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (enrolling)
• Irvine Clinical Research — Irvine, California, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Charter Research - Orlando — Orlando, Florida, United States (enrolling)
• Axiom Brain Health LLC — Tampa, Florida, United States (enrolling)
• Palm Beach Neurology — West Palm Beach, Florida, United States (enrolling)
• Conquest Research — Winter Park, Florida, United States (enrolling)
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States (enrolling)
• Brain Matters Research — Delray Beach, Florida, United States (enrolling)
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• K2 Medical Research - Foxborough — Foxborough, Massachusetts, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.