Donanemab for early memory and thinking decline with Lewy body features
Tests donanemab against placebo in people with early cognitive decline and Lewy body features.
Plain-language title generated from the registry record
Registry title: A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Key facts
- Where
- Atlantis, Aventura, Beaumont, Bolivar, Carlsbad, Chandler, Charlestown, Dallas, Delray Beach, Englewood, Fairfax, Fairway, Farmington Hills, Fort Myers, Foxborough, Gainesville, Golden Valley, Houston, Indianapolis, Irvine, Jacksonville, Kirkland, La Jolla, Maitland, Miami, Ocala, Orlando, Palo Alto, Philadelphia, Plymouth, Portland, Rochester, Round Rock, San Antonio, Scottsdale, Stamford, Tampa, West Palm Beach, and Winter Park, United StatesSee the 42 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Source: NCT07589595, who can take part
Where in United States
- JEM Research InstituteAtlantis, United StatesTaking people
- VIN - AventuraAventura, United StatesTaking people
- Gadolin ResearchBeaumont, United StatesTaking people
- Citizens Memorial Hospital DistrictBolivar, United StatesTaking people
- Profound Research LLCCarlsbad, United StatesTaking people
- TrialSphere CorpChandler, United StatesTaking people
- Massachusetts General Hospital - CharlestownCharlestown, United StatesNot yet recruiting
- Kerwin Medical CenterDallas, United StatesTaking people
- Brain Matters ResearchDelray Beach, United StatesTaking people
- CenExel Rocky Mountain Clinical ResearchEnglewood, United StatesTaking people
- Re:Cognition HealthFairfax, United StatesTaking people
- The University of Kansas - Clinical Research CenterFairway, United StatesNot yet recruiting
- QUEST Research InstituteFarmington Hills, United StatesTaking people
- Neuropsychiatric Research Center of Southwest FloridaFort Myers, United StatesTaking people
- K2 Medical Research - FoxboroughFoxborough, United StatesTaking people
- Neurology Center of New EnglandFoxborough, United StatesTaking people
- Norman Fixel Institute for Neurological Diseases (FIND)Gainesville, United StatesNot yet recruiting
- Struthers Parkinson's CenterGolden Valley, United StatesTaking people
- Houston Methodist HospitalHouston, United StatesTaking people
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- Indiana University Health Neuroscience CenterIndianapolis, United StatesTaking people
- Irvine Clinical ResearchIrvine, United StatesTaking people
- Mayo Clinic in FloridaJacksonville, United StatesNot yet recruiting
- EvergreenHealthKirkland, United StatesTaking people
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United StatesNot yet recruiting
- K2 Medical Research ORLANDOMaitland, United StatesTaking people
- BRP-Kendal LakesMiami, United StatesTaking people
- Renstar Medical ResearchOcala, United StatesTaking people
- Charter Research - OrlandoOrlando, United StatesTaking people
- Stanford Neuroscience Health CenterPalo Alto, United StatesTaking people
- Pennsylvania HospitalPhiladelphia, United StatesTaking people
- Headlands Eastern MA LLCPlymouth, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- Summit HeadlandsPortland, United StatesTaking people
- Mayo Clinic in Rochester, MinnesotaRochester, United StatesNot yet recruiting
- Central Texas Neurology ConsultantsRound Rock, United StatesTaking people
- The University of Texas Health Science CenterSan Antonio, United StatesTaking people
- HonorHealth Research InstituteScottsdale, United StatesTaking people
- Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United StatesTaking people
- Axiom Brain Health LLCTampa, United StatesTaking people
- Palm Beach NeurologyWest Palm Beach, United StatesTaking people
- Conquest ResearchWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07589595
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
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.
Inclusion: 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: Have previously received amyloid-targeting therapy; 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; 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.