Donanemab Clinical Trials (2026): 13 Studies for Alzheimer Disease & Dementia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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13 Donanemab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 7 indications (including Alzheimer Disease & Dementia) and 15,000 total planned enrollment. 5 Phase 3 Donanemab trials and 3 Phase 2, 1 Phase 4 are listed. 4 Donanemab clinical trials are actively recruiting at 1 U.S. site across 1 state. Most recent activity: NCT06566170 (Feb 2033).
Where to Participate: All Donanemab Trial Sites in the U.S. (1 site across 1 state)
Every actively recruiting Donanemabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | Rehabilitation & Neurological Services | Huntsville35805-4046 | NCT06566170 | Map |
Donanemab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | enrolling by invitation | completed | not yet recruiting | Total |
|---|---|---|---|---|---|---|
| P1 | 2 | 2 | ||||
| P2 | 1 | 2 | 3 | |||
| P2/P3 | 1 | 1 | ||||
| P3 | 4 | 1 | 5 | |||
| P4 | 1 | 1 | ||||
| N/A | 1 | 1 |
Recruiting Donanemab clinical trials (4)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06566170 | LY3002813A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease | — | Alzheimer Disease | 6,250 | Oct 2024 |
| NCT06996730 | PSEN1A 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 | P2/P3 | Autosomal Dominant Alzheimers Disease | 240 | Jan 2026 |
| NCT06911944 | ALADDINAmyloid Lowering for Alzheimer's in Down's With Donanemab Investigation | P4 | Down Syndrome (DS) | 60 | Aug 2026 |
| NCT07167966 | ATPAlzheimer's Tau Platform: Regimen A - AADvac1 | P2 | Preclinical Alzheimer's Disease | 450 | Nov 2026 |
Donanemab clinical trials by indication
Alzheimer Disease (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06566170 | LY3002813 | N/A | recruiting | A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease |
| NCT04437511 | LY3002813 | P3 | active not recruiting | A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) |
| NCT05508789 | LY3002813 | P3 | active not recruiting | A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) |
| NCT05026866 | LY3002813 | P3 | active not recruiting | A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) |
| NCT04640077 | LY3002813 | P2 | completed | A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) |
| NCT03367403 | TRAILBLAZER-ALZ | P2 | completed | A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) |
Healthy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05567159 | LY3002813 | P1 | completed | A Study of Donanemab (LY3002813) in Healthy Participants |
| NCT05533411 | LY3002813 | P1 | completed | A Study of Donanemab (LY3002813) in Healthy Chinese Participants |
Down Syndrome (DS) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06911944 | ALADDIN | P4 | not yet recruiting | Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation |
Preclinical Alzheimer's Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07167966 | ATP | P2 | enrolling by invitation | Alzheimer's Tau Platform: Regimen A - AADvac1 |
Autosomal Dominant Alzheimers Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06996730 | PSEN1 | P2/P3 | not yet recruiting | 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 |
Alzheimer's Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05738486 | LY3002813 | P3 | active not recruiting | A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) |
Mild Cognitive Impairment (MCI) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05108922 | LY3002813 | P3 | completed | A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) |
Donanemab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ALADDIN | NCT06911944 | P4 | not yet recruiting | Down Syndrome (DS) | 60 | — |
| LY3002813 | NCT04437511 | P3 | active not recruiting | Alzheimer Disease | 1,736 | — |
| LY3002813 | NCT05508789 | P3 | active not recruiting | Alzheimer Disease | 1,500 | — |
| LY3002813 | NCT05026866 | P3 | active not recruiting | Alzheimer Disease | 2,996 | — |
| LY3002813 | NCT05738486 | P3 | active not recruiting | Alzheimer's Disease | 1,175 | — |
| LY3002813 | NCT05108922 | P3 | completed | Mild Cognitive Impairment (MCI) | 148 | — |
| ATP | NCT07167966 | P2 | enrolling by invitation | Preclinical Alzheimer's Disease | 450 | — |
| LY3002813 | NCT04640077 | P2 | completed | Alzheimer Disease | 95 | — |
| TRAILBLAZER-ALZ | NCT03367403 | P2 | completed | Alzheimer Disease | 272 | — |
All Donanemab trials (13)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06566170 | LY3002813 | A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease | — | recruiting | 6,250 | Eli Lilly and Company | Oct 2024 |
| NCT06996730 | PSEN1 | 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 | P2/P3 | not yet recruiting | 240 | Banner Health | Jan 2026 |
| NCT06911944 | ALADDIN | Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation | P4 | not yet recruiting | 60 | Michael Rafii, MD, PhD | Aug 2026 |
| NCT04437511 | LY3002813 | A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) | P3 | active not recruiting | 1,736 | Eli Lilly and Company | Jun 2020 |
| NCT07167966 | ATP | Alzheimer's Tau Platform: Regimen A - AADvac1 | P2 | enrolling by invitation | 450 | Paul S. Aisen | Nov 2026 |
| NCT05508789 | LY3002813 | A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) | P3 | active not recruiting | 1,500 | Eli Lilly and Company | Oct 2022 |
| NCT05026866 | LY3002813 | A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | P3 | active not recruiting | 2,996 | Eli Lilly and Company | Aug 2021 |
| NCT05738486 | LY3002813 | A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) | P3 | active not recruiting | 1,175 | Eli Lilly and Company | Feb 2023 |
| NCT04640077 | LY3002813 | A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) | P2 | completed | 95 | Eli Lilly and Company | Nov 2020 |
| NCT05108922 | LY3002813 | A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) | P3 | completed | 148 | Eli Lilly and Company | Nov 2021 |
| NCT05567159 | LY3002813 | A Study of Donanemab (LY3002813) in Healthy Participants | P1 | completed | 42 | Eli Lilly and Company | Oct 2022 |
| NCT05533411 | LY3002813 | A Study of Donanemab (LY3002813) in Healthy Chinese Participants | P1 | completed | 36 | Eli Lilly and Company | Sep 2022 |
| NCT03367403 | TRAILBLAZER-ALZ | A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) | P2 | completed | 272 | Eli Lilly and Company | Dec 2017 |
Donanemab clinical trials: frequently asked questions
- How many Donanemab clinical trials are there?
- 13 Donanemab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 5 are marked completed.
- Are Donanemab clinical trials recruiting in 2026?
- Yes — 2 Donanemab trials are actively recruiting in 2026, with 1 U.S. site across 1 state. See the recruiting trials and the per-state site list further down this page.
- What conditions is Donanemab being studied for?
- Donanemab is being studied for Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Neurodegenerative Diseases and 16 more. The trials are grouped by indication on this page.
- What phase is Donanemab in?
- Donanemab clinical trials span 1 Phase 4, 5 Phase 3, 3 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Donanemab clinical trials?
- The lead sponsor across the most Donanemab trials is Eli Lilly and Company, with 3 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Donanemabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: