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

Active, not recruiting · Phase 3 · NCT05738486

Conditions: Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders

Research payments reported, 2025: $16.1M
U.S. investigators named: 44
Sites paid: 42
Planned or actual enrollment: 1,175

About the trial

Sponsor: Eli Lilly and Company
Tested: Donanemab (drug), Placebo (drug), Dexamethasone (drug)
Dates: Started 2023-02-28; completion 2027-05
Results posted: Yes

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

From ClinicalTrials.gov, last updated 2026-06-18. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Eli Lilly and Company reported $16.1M in research payments for this study in 2025 (90 payments).

Products named: Kisunla

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.

At a glance

About the trial

Industry funding

U.S. investigators named on this study

Sites paid to run it