NCT07589595 A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
| NCT ID | NCT07589595 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eli Lilly and Company |
| Condition | Cognitive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 350 participants in total. It began in 2026-05-20 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
✉ LillyTrials@Lilly.com📞 1-317-615-4559
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
Frequently Asked Questions
Who can join the NCT07589595 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07589595 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07589595 currently recruiting?
Yes, NCT07589595 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.
Where is the NCT07589595 trial being conducted?
This trial is being conducted at Chandler, United States, Scottsdale, United States, Carlsbad, United States, Irvine, United States and 11 additional locations.
Who is sponsoring the NCT07589595 clinical trial?
NCT07589595 is sponsored by Eli Lilly and Company. The principal investigator is 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) at Eli Lilly and Company. The trial plans to enroll 350 participants.