{"entity":{"id":"da-trial-trailblazer-alz2","kind":"trial","name":"TRAILBLAZER-ALZ 2","aka":[],"tldr":"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.","status":"completed","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT04437511","url":"https://clinicaltrials.gov/study/NCT04437511"},{"label":"FDA Kisunla","url":"https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease"}],"tags":["dementia-atlas"],"related":[],"cancers":["alzheimers-disease"],"sections":[],"technologies":[],"targets":[],"drugs":["da-donanemab"],"companies":["da-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04437511","phase":"3","setting":"Early Alzheimer’s disease","sponsor":"Eli Lilly","result":"The trial met its primary clinical endpoint versus placebo, with ARIA as the main safety issue.","yearReported":2023,"enrolled":1736,"outcomes":[{"endpoint":"Clinical scale change (primary)","primary":true,"arms":[{"name":"Donanemab","note":"Favoured versus placebo"},{"name":"Placebo"}],"source":"https://clinicaltrials.gov/study/NCT04437511"}]},"route":"/trials/da-trial-trailblazer-alz2/","neighbours":{"cancer":[{"id":"alzheimers-disease","kind":"cancer","name":"Alzheimer’s disease","route":"/diagnoses/alzheimers-disease/"}],"drug":[{"id":"da-donanemab","kind":"drug","name":"Donanemab","route":"/drugs/da-donanemab/"}],"company":[{"id":"da-lilly","kind":"company","name":"Eli Lilly","route":"/companies/da-lilly/"}]}}