> 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-6b98d37f-787d-4d2a-bde0-f027366b39c3 > Record changed: 2026-10-13 # A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) NCT05508789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Participants 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Start date 2022-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) Number of sites 141 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Title and summary **Summary** The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Short title** A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Official title** Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Dates **Completion date** 2028-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **First posted** 2022-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Primary completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Start date** 2022-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Size and sites **Participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Planned participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Number of sites** 141 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Identifiers **Registry ID** NCT05508789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **ClinicalTrials.gov ID** NCT05508789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## 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/NCT05508789) ## Outcomes ### Primary outcomes 1. Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Timeframe: Baseline, Week 76 Change from Baseline on the iADRS in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology population. ### Secondary outcomes 1. Change from Baseline on the iADRS Timeframe: Baseline, Week 76 Change from baseline on the iADRS in the overall population. 2. Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Timeframe: Baseline, Week 76 Change from Baseline CDR-SB in at least one of the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population. 3. Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score Timeframe: Baseline, Week 76 Change from Baseline on the ADAS-Cog13 Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population. 4. Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score Timeframe: Baseline, Week 76 Change from Baseline ADCS-iADL Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population. 5. Change from Baseline on the Mini Mental State Examination (MMSE) Score Timeframe: Baseline, Week 76 Change from Baseline on the MMSE Score in the low-medium tau pathology population, no-very low and low-medium tau pathology populations, and the overall population. 6. Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan Timeframe: Baseline, Week 76 Change in brain amyloid plaque deposition in the overall population. 7. Pharmacokinetics (PK): Trough Serum Concentration of Donanemab Timeframe: Baseline to Week 76 8. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) Timeframe: Week 76 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## 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 MMSE score of 20 to 28 (inclusive) at screening visit. - Meet amyloid scan (central read) criteria. - Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times. - A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered. - If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments. - Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments - AEs and concomitant medications - CDR, and - ADCS-ADL - Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization. ### Exclusion criteria - Has 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; or has a life expectancy of <24 months. - History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread. - Contraindication to MRI or PET scans. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## Sites - Hospital Italiano de Buenos AiresABB, Argentina - Clinica Privada BanfieldBanfield, Argentina - Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)Buenos Aires, Argentina - Stat Research S.A.Buenos Aires, Argentina - Centro de Investigaciones Metabólicas (CINME)Buenos Aires, Argentina - CIPRECBuenos Aires, Argentina - Mautalen Salud e InvestigaciónBuenos Aires, Argentina - Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, Argentina - Centro Médico ArsemaBuenos Aires, Argentina - Instituto Geriatrico Nuestra Señora de Las NievesBuenos Aires, Argentina - Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)Buenos Aires, Argentina - Buenos Aires, Argentina - IDIM - Instituto de Investigaciones MetabólicasCiudad de Buenos Aires, Argentina - INSA Instituto de Neurociencia San AgustinLa Plata, Argentina - Instituto De Investigaciones Clinicas QuilmesQuilmes, Argentina - INECO Neurociencias OroñoRosario, Argentina - Emeritus ResearchBotany, Australia - Box Hill HospitalBox Hill, Australia - The Prince Charles HospitalBrisbane, Australia - NeuroCentrixCarlton, Australia - Central Coast Neurosciences ResearchErina, Australia - Austin HealthIvanhoe, Australia - Southern NeurologyKogarah, Australia - HammondCareMalvern, Australia - The Alfred HospitalMelbourne, Australia And 116 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/356219) ### Other registry identifiers (3) - 2025 - 2025-522340-40-00 - I5T-MC-AACO Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05508789) ## 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 (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 (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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