Donanemab in Early Cognitive Decline with Lewy Body Features (TRAILBLAZER-ALZ 7)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study evaluating donanemab in participants with early cognitive decline who have Lewy body-related features and amyloid pathology. Participants will be randomized to receive donanemab or placebo for about 18 months, with assessments focused on cognitive and functional changes over time. The study requires biomarker confirmation of brain amyloid and alpha-synuclein pathology, plus a reliable study partner for support and consent. Multiple U.S. sites are enrolling eligible individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• TrialSphere Corp
  Chandler, Arizona, United States Recruiting
• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Profound Research LLC
  Carlsbad, California, United States Recruiting
• Irvine Clinical Research
  Irvine, California, United States Recruiting
• Stanford Neuroscience Health Center
  Palo Alto, California, United States Recruiting
• CenExel Rocky Mountain Clinical Research
  Englewood, Colorado, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.