Donanemab Clinical Trials (2026): 13 Studies for Alzheimer Disease & Dementia

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

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.

StateFacilityCityTrialMap
ALRehabilitation & Neurological ServicesHuntsville35805-4046NCT06566170Map

Donanemab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletednot yet recruitingTotal
P122
P2213
P2/P311
P3415
P411
N/A11

Recruiting Donanemab clinical trials (4)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06566170LY3002813A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's DiseaseAlzheimer Disease6,250Oct 2024
NCT06996730PSEN1A 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 DiseaseP2/P3Autosomal Dominant Alzheimers Disease240Jan 2026
NCT06911944ALADDINAmyloid Lowering for Alzheimer's in Down's With Donanemab InvestigationP4Down Syndrome (DS)60Aug 2026
NCT07167966ATPAlzheimer's Tau Platform: Regimen A - AADvac1P2Preclinical Alzheimer's Disease450Jun 2026

Donanemab clinical trials by indication

Alzheimer Disease (6)

NCTAcronymPhaseStatusTitle
NCT06566170LY3002813N/ArecruitingA Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
NCT04437511LY3002813P3active not recruitingA Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
NCT05508789LY3002813P3active not recruitingA Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
NCT05026866LY3002813P3active not recruitingA Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
NCT04640077LY3002813P2completedA Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
NCT03367403TRAILBLAZER-ALZP2completedA Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Healthy (2)

NCTAcronymPhaseStatusTitle
NCT05567159LY3002813P1completedA Study of Donanemab (LY3002813) in Healthy Participants
NCT05533411LY3002813P1completedA Study of Donanemab (LY3002813) in Healthy Chinese Participants

Down Syndrome (DS) (1)

NCTAcronymPhaseStatusTitle
NCT06911944ALADDINP4not yet recruitingAmyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Preclinical Alzheimer's Disease (1)

NCTAcronymPhaseStatusTitle
NCT07167966ATPP2not yet recruitingAlzheimer's Tau Platform: Regimen A - AADvac1

Autosomal Dominant Alzheimers Disease (1)

NCTAcronymPhaseStatusTitle
NCT06996730PSEN1P2/P3not yet recruitingA 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)

NCTAcronymPhaseStatusTitle
NCT05738486LY3002813P3active not recruitingA Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Mild Cognitive Impairment (MCI) (1)

NCTAcronymPhaseStatusTitle
NCT05108922LY3002813P3completedA 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
ALADDINNCT06911944P4not yet recruitingDown Syndrome (DS)60
LY3002813NCT04437511P3active not recruitingAlzheimer Disease1,736
LY3002813NCT05508789P3active not recruitingAlzheimer Disease1,500
LY3002813NCT05026866P3active not recruitingAlzheimer Disease2,996
LY3002813NCT05738486P3active not recruitingAlzheimer's Disease1,175
LY3002813NCT05108922P3completedMild Cognitive Impairment (MCI)148
ATPNCT07167966P2not yet recruitingPreclinical Alzheimer's Disease450
LY3002813NCT04640077P2completedAlzheimer Disease95
TRAILBLAZER-ALZNCT03367403P2completedAlzheimer Disease272

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06566170LY3002813A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Diseaserecruiting6,250Eli Lilly and CompanyOct 2024
NCT06996730PSEN1A 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 DiseaseP2/P3not yet recruiting240Banner HealthJan 2026
NCT06911944ALADDINAmyloid Lowering for Alzheimer's in Down's With Donanemab InvestigationP4not yet recruiting60Michael Rafii, MD, PhDAug 2026
NCT04437511LY3002813A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)P3active not recruiting1,736Eli Lilly and CompanyJun 2020
NCT07167966ATPAlzheimer's Tau Platform: Regimen A - AADvac1P2not yet recruiting450Paul S. AisenJun 2026
NCT05508789LY3002813A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)P3active not recruiting1,500Eli Lilly and CompanyOct 2022
NCT05026866LY3002813A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)P3active not recruiting2,996Eli Lilly and CompanyAug 2021
NCT05738486LY3002813A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)P3active not recruiting1,175Eli Lilly and CompanyFeb 2023
NCT04640077LY3002813A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)P2completed95Eli Lilly and CompanyNov 2020
NCT05108922LY3002813A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)P3completed148Eli Lilly and CompanyNov 2021
NCT05567159LY3002813A Study of Donanemab (LY3002813) in Healthy ParticipantsP1completed42Eli Lilly and CompanyOct 2022
NCT05533411LY3002813A Study of Donanemab (LY3002813) in Healthy Chinese ParticipantsP1completed36Eli Lilly and CompanySep 2022
NCT03367403TRAILBLAZER-ALZA Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)P2completed272Eli Lilly and CompanyDec 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. 1 is actively recruiting participants. 5 are marked completed.
Are Donanemab clinical trials recruiting in 2026?
Yes — 1 Donanemab trial is 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.

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