[{"id":"da-trial-clarity-ad","kind":"trial","name":"CLARITY AD","aka":[],"tldr":"CLARITY AD tested lecanemab in early Alzheimer’s disease. It is the main efficacy trial behind the US traditional approval.","summary":"A randomised, placebo-controlled phase 3 study in early symptomatic Alzheimer’s disease with confirmed amyloid. Primary clinical scale results favoured lecanemab. ARIA occurred, more often in ApoE ε4 carriers. This atlas does not treat a mean scale change as a promise for an individual.","status":"completed","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT03887455","url":"https://clinicaltrials.gov/study/NCT03887455"},{"label":"FDA traditional approval","url":"https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval"}],"tags":["dementia-atlas"],"related":[],"cancers":["alzheimers-disease"],"sections":[],"technologies":[],"targets":[],"drugs":["da-lecanemab"],"companies":["da-eisai","da-biogen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03887455","phase":"3","setting":"Early Alzheimer’s disease","sponsor":"Eisai","result":"The trial met its primary clinical endpoint versus placebo. ARIA was the principal safety theme. See the FDA approval communication for the regulator’s reading.","yearReported":2023,"enrolled":1795,"outcomes":[{"endpoint":"Clinical scale change (primary)","primary":true,"unit":"points","arms":[{"name":"Lecanemab","note":"Favoured versus placebo on the primary scale"},{"name":"Placebo"}],"source":"https://clinicaltrials.gov/study/NCT03887455"}]},{"id":"da-trial-engage","kind":"trial","name":"ENGAGE","aka":[],"tldr":"ENGAGE was a phase 3 aducanumab trial that did not meet its primary endpoint as designed. It is here as a failure, not as support for using the drug.","summary":"One of two large aducanumab trials. ENGAGE did not meet its primary endpoint. The later US accelerated approval was withdrawn. Failure trials belong in a map so positive trials are not the only story.","status":"negative","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT02477800","url":"https://clinicaltrials.gov/study/NCT02477800"}],"tags":["dementia-atlas"],"related":[],"cancers":["alzheimers-disease"],"sections":[],"technologies":[],"targets":[],"drugs":["da-aducanumab"],"companies":["da-biogen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477800","phase":"3","setting":"Early Alzheimer’s disease","sponsor":"Biogen","result":"Primary endpoint not met as designed. Historical context for aducanumab, which is not a current US option.","yearReported":2019,"enrolled":1647,"outcomes":[{"endpoint":"Primary clinical endpoint","primary":true,"arms":[{"name":"Aducanumab","note":"Did not meet the primary endpoint as designed"},{"name":"Placebo"}],"source":"https://clinicaltrials.gov/study/NCT02477800"}]},{"id":"da-trial-expedition3","kind":"trial","name":"EXPEDITION 3","aka":[],"tldr":"EXPEDITION 3 tested solanezumab in mild Alzheimer’s disease and did not meet its primary endpoint. It is included as a negative amyloid-antibody result.","summary":"A large phase 3 trial of an amyloid antibody that did not slow clinical decline as designed. Listed so the pipeline layer includes failures, not only approvals.","status":"negative","asOf":"2026-09-21","links":[{"label":"ClinicalTrials.gov NCT01900665","url":"https://clinicaltrials.gov/study/NCT01900665"}],"tags":["dementia-atlas"],"related":[],"cancers":["alzheimers-disease"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01900665","phase":"3","setting":"Mild Alzheimer’s disease","sponsor":"Eli Lilly","result":"Primary endpoint not met.","yearReported":2016,"enrolled":2129,"outcomes":[{"endpoint":"Primary clinical endpoint","primary":true,"arms":[{"name":"Solanezumab","note":"Did not meet the primary endpoint"},{"name":"Placebo"}],"source":"https://clinicaltrials.gov/study/NCT01900665"}]},{"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"}]}]