Donanemab

DRUG15 trials

Sponsors

Eli Lilly & Co., Eli Lilly and Company, Michael Rafii, MD, PhD, Banner Health

Conditions

Alzheimer DiseaseAlzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental DisordersAlzheimer's DiseaseAlzheimers DiseaseAlzheimer’s DiseaseAmyloid Beta ProteinAutosomal Dominant Alzheimers DiseaseBrain Diseases

Phase 1

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

CompletedNCT05533411

Eli Lilly and CompanyHealthy

Start: 2022-09-14End: 2023-01-05Updated: 2024-10-04

A Study of Donanemab (LY3002813) in Healthy Participants

CompletedNCT05567159

Eli Lilly and CompanyHealthy

Start: 2022-10-04End: 2023-07-14Updated: 2024-10-04

Phase 2

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

CompletedNCT03367403

Eli Lilly and CompanyAlzheimer Disease

Start: 2017-12-18End: 2021-09-21Updated: 2026-03-19

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

CompletedNCT04640077

Eli Lilly and CompanyAlzheimer Disease, Brain Diseases, Central Nervous System Diseases +2

Start: 2020-11-23End: 2024-02-27Updated: 2025-06-13

I5T-MC-AACI: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

CompletedCTIS2023-507303-55-00

Eli Lilly & Co.Alzheimer Disease

Start: 2020-09-30End: 2025-09-17Target: 224Updated: 2025-01-23

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

Not yet recruitingNCT06996730

Banner HealthAlzheimers Disease, Autosomal Dominant Alzheimers Disease, Early Onset Alzheimer Disease

Start: 2026-01-15End: 2030-06-01Target: 240Updated: 2025-08-03

Phase 3

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Active, not recruitingNCT04437511

Eli Lilly and CompanyAlzheimer Disease

Start: 2020-06-19End: 2028-11-30Updated: 2025-08-29

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Active, not recruitingNCT05026866

Eli Lilly and CompanyAlzheimer Disease

Start: 2021-08-27End: 2027-11-01Target: 2996Updated: 2026-01-21

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

CompletedNCT05108922

Eli Lilly and CompanyAlzheimer Disease, Mild Cognitive Impairment (MCI)

Start: 2021-11-16End: 2023-09-19Updated: 2024-11-29

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

RecruitingNCT05508789

Eli Lilly and CompanyAlzheimer Disease, Brain Diseases, Central Nervous System Diseases +6

Start: 2022-10-10End: 2028-07-01Target: 1500Updated: 2026-03-27

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Active, not recruitingNCT05738486

Eli Lilly and CompanyAlzheimer's Disease, Brain Diseases, Central Nervous System Diseases +5

Start: 2023-02-28End: 2027-05-31Updated: 2025-11-14

I5T-MC-AACQ: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults with Early Symptomatic Alzheimer’s Disease

CompletedCTIS2022-502268-18-00

Eli Lilly & Co.Alzheimer’s Disease, Brain Diseases, Central Nervous System Diseases +5

End: 2024-03-19Target: 56Updated: 2023-04-07

I5T-MC-AACO: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease

RecruitingCTIS2025-522340-40-00

Eli Lilly & Co.Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

Start: 2025-12-04Target: 170Updated: 2026-01-19

Phase 4

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Not yet recruitingNCT06911944

Michael Rafii, MD, PhDAlzheimer Disease, Amyloid Beta Protein, Down Syndrome (DS) +1

Start: 2026-08-01End: 2028-12-31Target: 60Updated: 2025-11-24

Unknown Phase

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

RecruitingNCT06566170

Eli Lilly and CompanyAlzheimer Disease

Start: 2024-10-07End: 2033-02-28Target: 6250Updated: 2025-10-09

Related Papers

Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension.

2025-12-01

Posttreatment Amyloid Levels and Clinical Outcomes Following Donanemab for Early Symptomatic Alzheimer Disease: A Secondary Analysis of the TRAILBLAZER-ALZ 2 Randomized Clinical Trial.

2025-12-01

Implementation of task‐based fMRI in TRAILBLAZER‐ALZ 6 Phase 3b study: Methodological considerations

Alzheimer s & Dementia2025-12-01

Flortaucipir patterns in preclinical Alzheimer’s disease: an evaluation of TRAILBLAZER‐ALZ 3 baseline data

Alzheimer s & Dementia2025-12-01

Comparable cumulative exposure and amyloid reduction following donanemab standard and modified titration dosing in participants with early symptomatic Alzheimer’s disease from TRAILBLAZER‐ALZ 6

Alzheimer s & Dementia2025-12-01

Association of Occipital Amyloid PET Burden with ARIA‐E: Exploratory Analyses in Three Clinical Trials of Donanemab

Alzheimer s & Dementia2025-12-01

Leveraging digital twins for sample size reduction, powering secondary endpoints or subgroups in a simulated TRAILBLAZER‐ALZ 2 trial

Alzheimer s & Dementia2025-12-01

Flortaucipir patterns in preclinical Alzheimer's disease: an evaluation of TRAILBLAZER‐ALZ 3 baseline data

Alzheimer s & Dementia2025-12-01

Donanemab physiologically based pharmacokinetic model coupled with natural life cycle model for amyloid plaque aggregation to predict target CSF and ISF concentrations associated with amyloid plaque reduction

Alzheimer s & Dementia2025-12-01

Association of Occipital Amyloid PET Burden with ARIA‐E: Exploratory Analyses in Three Clinical Trials of Donanemab

Alzheimer s & Dementia2025-12-01

Regional tau quantification methodologies in early symptomatic participants with presence of tau pathology

Alzheimer s & Dementia2025-12-01

Implementation of task‐based fMRI in TRAILBLAZER‐ALZ 6 Phase 3b study: Methodological considerations

Alzheimer s & Dementia2025-12-01

Tau PET and Plasma <i>p</i> ‐tau217 as Independent and Synergistic Predictors of Clinical Progression in Early Symptomatic AD Patients With Amyloid and Tau Pathology

Alzheimer s & Dementia2025-12-01

Characterizing early symptomatic AD patients by visual and quantitative tau profiles

Alzheimer s & Dementia2025-12-01

Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER‐ALZ 3

Alzheimer s & Dementia2025-09-013 citations

The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6.

2025-07-05

Donanemab exposure‐response in early symptomatic Alzheimer's disease

Alzheimer s & Dementia2025-07-015 citations

Donanemab immunogenicity in participants with early symptomatic Alzheimer's disease

Alzheimer s & Dementia Translational Research & Clinical Interventions2025-07-011 citations

The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity.

2025-07-01

TRAILBLAZER‐ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease

Alzheimer s & Dementia2025-05-0112 citations

24 more papers not shown