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Donanemab for Early Cognitive Decline in Lewy Body Disease

This study is testing a drug called donanemab to see if it can slow down problems with thinking, learning, remembering, and daily activities in people with early cognitive decline. You might be able to join if you are between 55 and 85 years old, have experienced gradual memory decline for at least six months, and have features of Lewy body disease. To be eligible, you'll also need to meet specific criteria based on blood and spinal fluid tests that show signs of amyloid in the brain. Participants will receive either donanemab or a placebo (an inactive substance) through an IV. The main goal is to see how much your thinking abilities change over about one year. The study is planning to enroll 350 people, but its current recruitment status is unclear.

Study design
This interventional study is designed to enroll 350 participants. Participants will receive either donanemab or a placebo via IV.
What's involved
The study will last one and a half years for each participant. The primary endpoint measures changes in cognitive function from the start of the study through Week 52.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes from baseline through Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07589595

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

Recruiting
PHASE2Ages 55–85InterventionalTreatment
Eli Lilly and Company
~350 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:DonanemabPlacebo

At a glance

Recruiting sites
29 of 72 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Measured over Baseline through Week 52

Conditions

Cognitive Dysfunction
Lewy Body Disease
Synucleinopathies
Amyloid

Explore related trials

Alzheimer's DiseaseLewy Body DementiaMild cognitive disorderMild dementiaAlpha-SynucleinAmyloid beta peptideP-tau217

Where it's being run

72 sites across 19 states
Japan18
Florida13
Texas6
South Korea6
Taiwan6
California4
Massachusetts4
Arizona2

Study leadership

  • Call 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

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)Baseline through Week 52