5 completed, 5 recruiting, 4 active not recruiting, 2 not yet recruiting. 8 Phase 3, 5 Phase 2, 2 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Active not recruiting 4, Recruiting 3, Completed 1 |
| Phase 2 | 5 | Completed 2, Recruiting 2, Enrolling by invitation 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 2 | Not yet recruiting 2 |
Follow donanemab: new trials by email Literature Review of donanemab trials Research Report on donanemab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Alzheimer's Tau Platform: Regimen A - AADvac1 AADvac1, Donanemab - Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease | Phase 2 | Enrolling by invitation | Paul S. Aisen | 450 | 2026-11-03 | 2026-10-26 |
| A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease Donanemab - Alzheimer Disease | Phase 4 | Not yet recruiting | Eli Lilly and Company | 50 | 2026-11-01 | 2026-10-15 |
| Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation Donanemab, Placebo - Down Syndrome (DS), Down Syndrome (Trisomy 21) | Phase 4 | Not yet recruiting | Michael Rafii, MD, PhD | 60 | 2026-08-01 | 2026-05-15 |
| A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease Donanemab, RG6289, Donanemab placebo - Autosomal Dominant Alzheimers Disease, Early Onset Alzheimer Disease | Phase 2 / Phase 3 | Recruiting | Banner Health | 240 | 2026-07-08 | 2026-09-02 |
| A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). Donanemab, Placebo - Alzheimer Disease, Dementia | Phase 3 | Recruiting | Eli Lilly and Company | 550 | 2026-05-22 | 2026-10-28 |
| A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) Donanemab, Placebo - Cognitive Dysfunction, Lewy Body Disease | Phase 2 | Recruiting | Eli Lilly and Company | 350 | 2026-05-20 | 2026-10-08 |
| Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease Donanemab, Placebo - Alzheimer Disease | Phase 3 | Recruiting | Eli Lilly and Company | 140 | 2026-04-30 | 2026-08-24 |
| A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease Donanemab, Usual Care - Alzheimer Disease | Recruiting | Eli Lilly and Company | 6250 | 2024-10-07 | 2026-10-20 | |
| A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) Donanemab, Placebo, Dexamethasone - Alzheimer's Disease, Dementia | Phase 3 | Active not recruiting | Eli Lilly and Company | 1175 | 2023-02-28 | 2026-06-18 |
| A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Donanemab, Placebo - Alzheimer Disease, Dementia | Phase 3 | Active not recruiting | Eli Lilly and Company | 1500 | 2022-10-10 | 2026-09-22 |
| A Study of Donanemab (LY3002813) in Healthy Participants Donanemab - Healthy | Phase 1 | Completed | Eli Lilly and Company | 42 | 2022-10-04 | 2024-10-04 |
| A Study of Donanemab (LY3002813) in Healthy Chinese Participants Donanemab, Placebo - Healthy | Phase 1 | Completed | Eli Lilly and Company | 36 | 2022-09-14 | 2024-10-04 |
| A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) Donanemab, Aducanumab - Mild Cognitive Impairment (MCI), Alzheimer Disease | Phase 3 | Completed | Eli Lilly and Company | 148 | 2021-11-16 | 2024-11-29 |
| A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) Donanemab, Placebo - Alzheimer Disease | Phase 3 | Active not recruiting | Eli Lilly and Company | 2996 | 2021-08-27 | 2026-01-21 |
| A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) No Intervention, donanemab - Alzheimer Disease, Dementia | Phase 2 | Completed | Eli Lilly and Company | 95 | 2020-11-23 | 2025-06-13 |
| A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) Donanemab, Placebo - Alzheimer Disease | Phase 3 | Active not recruiting | Eli Lilly and Company | 1736 | 2020-06-19 | 2026-08-26 |
| A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) Donanemab, Placebo, LY3202626 - Alzheimer Disease | Phase 2 | Completed | Eli Lilly and Company | 272 | 2017-12-18 | 2026-03-19 |
Alzheimer Disease (15) · Dementia (6) · Cognitive Dysfunction (5) · Brain Diseases (4) · Plaque, Amyloid (4) · Central Nervous System Diseases (3) · Nervous System Diseases (3) · Neurocognitive Disorders (3) · Neurodegenerative Diseases (3) · Mental Disorders (2) · Cognition Disorders (1) · Down Syndrome (1) · Lewy Body Disease (1) · Pick Disease of the Brain (1) · Synucleinopathies (1)
Eli Lilly and Company (14) · Banner Health (1) · Michael Rafii, MD, PhD (1) · Paul S. Aisen (1)
United States (11) · Japan (4) · Canada (3) · China (3) · Puerto Rico (3) · United Kingdom (3) · Australia (2) · Poland (2) · South Korea (2) · Taiwan (2) · Argentina (1) · Colombia (1) · Czechia (1) · India (1) · Netherlands (1)
Adam Boxer, MD, PhD (1) · Eric Reiman, M.D. (1) · Jessica Langbaum, Ph.D. (1) · Keith Johnson, MD (1) · Michael Rafii, MD, PhD (1) · Robert Alexander, M.D. (1) · Yakeel T. Quiroz-Gaviria, Ph.D. (1)
PMID 41804324, PMID 40667684, PMID 38323738, PMID 40063015, PMID 40603145, PMID 42552749, PMID 42644303, PMID 33720637, PMID 36094645, PMID 36251300, PMID 36934371, PMID 37459141, PMID 38581616, PMID 39292433, PMID 40172303, PMID 40390253, PMID 40619285, PMID 40955720, PMID 41082199, PMID 41330788, PMID 42128444, PMID 42273802
2025 (1), R01AG078457 (1), R01AG086363 (1), R33AG066543 (1)