{"entity":{"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"}]},"route":"/trials/da-trial-clarity-ad/","neighbours":{"cancer":[{"id":"alzheimers-disease","kind":"cancer","name":"Alzheimer’s disease","route":"/diagnoses/alzheimers-disease/"}],"drug":[{"id":"da-lecanemab","kind":"drug","name":"Lecanemab","route":"/drugs/da-lecanemab/"}],"company":[{"id":"da-biogen","kind":"company","name":"Biogen","route":"/companies/da-biogen/"},{"id":"da-eisai","kind":"company","name":"Eisai","route":"/companies/da-eisai/"}],"paper":[{"id":"da-paper-clarity-ad","kind":"paper","name":"Lecanemab in Early Alzheimer’s Disease (CLARITY AD)","route":"/key-papers/da-paper-clarity-ad/"}]}}