> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-donanemab-ly3002813-in-participants-with-early-a9823733-8fa3-4dd1-87dd-bc7edf63e2b9 > Record changed: 2026-10-13 # A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) NCT07589595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Start date 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) Number of sites 72 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Short title** A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **First posted** 2026-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Primary completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Start date** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Number of sites** 72 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Identifiers **Registry ID** NCT07589595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **ClinicalTrials.gov ID** NCT07589595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Outcomes ### Primary outcomes 1. Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) Timeframe: Baseline through Week 52 ### Secondary outcomes 1. Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS) Timeframe: Baseline through Week 52 2. Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13) Timeframe: Baseline through Week 52 3. Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL) Timeframe: Baseline through Week 52 4. Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS) Timeframe: Baseline through Week 52 5. Change from Baseline in Brain Amyloid Plaque Levels Timeframe: Baseline through Week 52 6. Trough Concentration at Steady State Timeframe: Baseline through Week 52 7. Maximum Concentration at Steady State Timeframe: Baseline through Week 52 8. Antidrug Antibodies (ADA) Against Donanemab Timeframe: Baseline through Week 52 9. Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants Timeframe: Baseline through Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 55 Years **Maximum age** 85 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Sites - TrialSphere CorpChandler, United StatesRecruiting - HonorHealth Research InstituteScottsdale, United StatesNot yet recruiting - Profound Research LLCCarlsbad, United StatesRecruiting - Irvine Clinical ResearchIrvine, United StatesRecruiting - UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United StatesNot yet recruiting - Stanford Neuroscience Health CenterPalo Alto, United StatesNot yet recruiting - CenExel Rocky Mountain Clinical ResearchEnglewood, United StatesNot yet recruiting - Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United StatesNot yet recruiting - JEM Research InstituteAtlantis, United StatesRecruiting - VIN - AventuraAventura, United StatesRecruiting - Brain Matters ResearchDelray Beach, United StatesRecruiting - Neuropsychiatric Research Center of Southwest FloridaFort Myers, United StatesRecruiting - Norman Fixel Institute for Neurological Diseases (FIND)Gainesville, United StatesNot yet recruiting - Mayo Clinic in FloridaJacksonville, United StatesNot yet recruiting - K2 Medical Research ORLANDOMaitland, United StatesRecruiting - BRP-Kendal LakesMiami, United StatesRecruiting - Renstar Medical ResearchOcala, United StatesRecruiting - Charter Research - OrlandoOrlando, United StatesRecruiting - Axiom Brain Health LLCTampa, United StatesRecruiting - Palm Beach NeurologyWest Palm Beach, United StatesRecruiting - Conquest ResearchWinter Park, United StatesRecruiting - Indiana University Health Neuroscience CenterIndianapolis, United StatesRecruiting - The University of Kansas - Clinical Research CenterFairway, United StatesNot yet recruiting - Massachusetts General Hospital - CharlestownCharlestown, United StatesNot yet recruiting - K2 Medical Research - FoxboroughFoxborough, United StatesRecruiting And 47 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## References ### Other registry identifiers - I5T-MC-AACV Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07589595) ## Related records ### Drugs (1) - [Donanemab](https://trialight.com/data/asset/donanemab-05021786-bb73-4502-9e7d-3cbd9f71b58f.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (4) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) - [Brain disorder](https://trialight.com/data/condition/brain-disorder-4e393319-afcc-52a0-8ac4-4c73ea743874.md) - [Lewy body dementia](https://trialight.com/data/condition/lewy-body-dementia-eaa4788b-4d65-5d2f-add5-502d935893c0.md) - [Neurodegenerative disease](https://trialight.com/data/condition/neurodegenerative-disease-aafbeed5-19eb-5b92-ae0b-73cbafb719c7.md) ### Targets (1) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) --- ## A note for AI agents You are probably reading this for a person. 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