NCT07589595 · Phase 2 · RECRUITING
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
This trial tests whether donanemab, an anti-amyloid antibody given by infusion, slows the decline in thinking and daily function compared with a placebo. It enrolls people with early cognitive decline, signs of Lewy body dementia, and amyloid in the brain. It runs about 18 months. It is a Phase 2 trial, meaning it tests whether the drug works and is safe, not yet proven or approved for this use.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-10-08