A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Donanemab
- Placebo
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov