# TRAILBLAZER-ALZ 2

Source: https://onco.cc/trials/da-trial-trailblazer-alz2/  
OnCo record `da-trial-trailblazer-alz2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TRAILBLAZER-ALZ 2 tested donanemab in early Alzheimer’s disease and is the main efficacy trial behind the US approval.

## Summary

Phase 3, randomised, placebo-controlled. Clinical scale results favoured donanemab in the enrolled early-stage population. ARIA was the principal safety theme. Stopping after plaque clearance is a label discussion, not a community protocol.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-21
- Tags: dementia-atlas
- Registry id: NCT04437511
- Phase: 3
- Setting: Early Alzheimer’s disease
- Sponsor: Eli Lilly
- Enrolled: 1736
- Result: The trial met its primary clinical endpoint versus placebo, with ARIA as the main safety issue.
- Outcomes: Clinical scale change (primary): Donanemab vs Placebo

## Sources

- ClinicalTrials.gov NCT04437511: https://clinicaltrials.gov/study/NCT04437511
- FDA Kisunla: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease

## Connected records

- diagnoses: [Alzheimer’s disease](https://onco.cc/diagnoses/alzheimers-disease/)
- drugs: [Donanemab](https://onco.cc/drugs/da-donanemab/)
- companies: [Eli Lilly](https://onco.cc/companies/da-lilly/)

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