> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-different-donanemab-ly3002813-dosing-regimens-in-735daf1d-fa4f-411c-bae8-ee9ff8d0c703 > Record changed: 2026-10-13 # A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) NCT05738486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Participants 1,175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Start date 2023-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) Number of sites 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Title and summary **Summary** This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2\. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Short title** A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Official title** Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Dates **Completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **First posted** 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Registry last updated** 2026-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Primary completion date** 2024-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Start date** 2023-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Size and sites **Actual participants** 1,175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Participants** 1,175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Number of sites** 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Identifiers **Registry ID** NCT05738486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **ClinicalTrials.gov ID** NCT05738486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) Timeframe: 24 Weeks Percentage of participants with occurrence of ARIA-E at Week 24 is reported here. ### Secondary outcomes 1. Percentage of Participants With Any Occurrence of ARIA-E Timeframe: 52 Weeks Outcome data will be provided after the study is completed. 2. Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan Timeframe: Baseline, 76 Weeks Outcome data will be provided after the study is completed. 3. Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H) Timeframe: 24 Weeks Percentage of participants with occurrence of ARIA-H at Week 24 is reported here. 4. Percentage of Participants With ARIA-H Timeframe: 52 Weeks Outcome data will be provided after the study is completed. 5. Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H Timeframe: 76 Weeks Outcome data will be provided after the study is completed. 6. Pharmacokinetics (PK): Average Serum Concentration of Donanemab Timeframe: Baseline to 76 Weeks Outcome data will be provided after the study is completed. 7. Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies Timeframe: Baseline to End of Follow-Up (91 Weeks) Outcome data will be provided after the study is completed. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria - Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. - A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening. - Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology. ### Exclusion criteria - Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures. - Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study. - A life expectancy of <24 months. - Contraindication to MRI or PET scans - Have had prior treatment with a passive anti-amyloid immunotherapy. - Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1. Exceptions: - non-metastatic basal- or squamous-cell skin cancer - Stage 0 non-invasive carcinoma of the cervix - Stage 0 non-invasive prostate cancer, or - other cancers with low risk of recurrence or spread Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Sites - MD First Research - ChandlerChandler, United States - Irvine Clinical ResearchIrvine, United States - Healthy Brain ClinicLong Beach, United States - California Neuroscience Research Medical Group, Inc.Sherman Oaks, United States - JEM Research InstituteAtlantis, United States - VIN-Julie SchwartzbardAventura, United States - Excel Medical Clinical TrialsBoca Raton, United States - K2 Medical ResearchClermont, United States - Brain Matters ResearchDelray Beach, United States - Neuropsychiatric Research Center of Southwest FloridaFort Myers, United States - Finlay Medical ResearchGreenacres City, United States - Infinity Clinical Research, LLCHollywood, United States - Jacksonville Center for Clinical ResearchJacksonville, United States - ClinCloud - MaitlandMaitland, United States - K2 Medical ResearchMaitland, United States - ClinCloud - VieraMelbourne, United States - Suncoast Clinical Research, Inc.New Port Richey, United States - Renstar Medical ResearchOcala, United States - Charter Research - Winter ParkOrlando, United States - Progressive Medical ResearchPort Orange, United States - Alzheimer's Research and Treatment CenterStuart, United States - K2 Medical Research - TampaTampa, United States - K2 Summit ResearchThe Villages, United States - Charter Research - Lady LakeThe Villages, United States - Alzheimer's Research and Treatment CenterWellington, United States And 24 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## References - PubMed 42552749 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42552749/) Related publication - PubMed 40619285 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40619285/) Related publication - PubMed 40172303 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40172303/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/389475) ### Other registry identifiers (3) - U1111-1285-9438 - 2022-502268-18-00 - I5T-MC-AACQ Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05738486) ## Related records ### Drugs (2) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) - [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 (6) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition - [Brain disorder](https://trialight.com/data/condition/brain-disorder-4e393319-afcc-52a0-8ac4-4c73ea743874.md) - [Central nervous system disorder](https://trialight.com/data/condition/central-nervous-system-disorder-78230ae5-4e6b-5495-ac04-050b0e11e964.md) - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) - [Mental disorder](https://trialight.com/data/condition/mental-disorder-6dfe385f-02c0-52b1-895d-e6ed79c12e5f.md) - [Neurodegenerative disease](https://trialight.com/data/condition/neurodegenerative-disease-aafbeed5-19eb-5b92-ae0b-73cbafb719c7.md) ### Targets (2) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) --- ## A note for AI agents You are probably reading this for a person. 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