{"id":"nct:NCT03887455","kind":"trial","title":"A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease","authors":["Eisai Inc."],"author_count":1,"year":2019,"published":"2019-03-25","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT03887455","source_url":"https://clinicaltrials.gov/study/NCT03887455","archive_url":"https://space-kitty.com/papers/nct:NCT03887455","updated":"2026-10-06","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Early Alzheimer's Disease"],"details":{"acronym":"Clarity AD","status":"ACTIVE_NOT_RECRUITING","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":1906,"sponsor":"Eisai Inc.","conditions":["Early Alzheimer's Disease"],"interventions":["DRUG: Lecanemab IV","DRUG: Placebo","DRUG: Lecanemab SC"],"start_date":"2019-03-27","start_date_type":"ACTUAL","primary_completion_date":"2026-12-31","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"neurodegeneration","name":"Alzheimer's, Parkinson's & Neurodegeneration","domain_slug":"medicine"}],"cited_in_dossiers":[]}