A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) (NCT07589595) | Clinical Trial Compass
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
United States, Japan, South Korea350 participantsStarted 2026-05-20
Plain-language summary
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.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 criteri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing donanemab in people with Lewy body disease and early cognitive decline — given that my diagnosis involves Lewy body pathology, does my specific situation look anything like who this study is designed for, and would it even be worth monitoring as it opens?
2Since this is a Phase 2 trial and it hasn't started recruiting yet, what does that mean practically — would there be less long-term safety data available compared to an already-established treatment, and how should I weigh that uncertainty?
3The trial is measuring cognitive change using something called the CDR-SB scale — can you help me understand what that measures and whether changes on that scale would translate to something meaningful in day-to-day life for me or my family?
4Donanemab targets amyloid, but Lewy body disease also involves a different protein called alpha-synuclein — is there any concern that treating the amyloid side alone might not address what's actually driving my symptoms?
5Before this trial even opens for recruitment, are there other ongoing studies or currently available treatments I should be considering now, so I'm not in a holding pattern while waiting for something that may take time to become accessible?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Timeframe: Baseline through Week 52
Trial details
NCT IDNCT07589595
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-08
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or