A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
← catalyst calendarNCT05508789 · readout ≤ 650 d
Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
1,500estimated
Sites
141
Countries
Argentina, Australia, China +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-10-10 | actual | When the study began enrolling |
| Primary completion | May 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
Interventions
- Drug: Donanemab — also filed as (LY3002813)
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
measured Baseline, Week 76
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