Biogen EMBARK Study

The Biogen EMBARK Trial is a phase III clinical drug trial to evaluate safety and tolerability of aducanumab in participants with Alzheimer's disease who had previously participated in the earlier aducanumab studies. 

Title: Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer’s disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Short title: EMBARK

Sponsor: Biogen Idec Research Limited

Chief Investigator: 

Edinburgh PI: Prof Craig Ritchie, University of Edibnburgh

Ethics ref: 20/NW/0177

Funder: Biogen Idec Research Limited

Dates (estimated): March 2020 - February 2025

Synopsis: Edinburgh Dementia Prevention are working in partnership with the NHS Lothian Clinical Research Facilities to deliver the study, which is part of a multi-site European wide project.  Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from previous phases of the study on patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has shown the potential to impact underlying disease pathophysiology, slow cognitive functional decline and provide benefits on patients’ ability to perform activities of daily living. The current phase of the study seeks to evaluate Aducanamab at higher dosages, where it may have the most significant impact.  

Aims:  To evaluate the safety and tolerability of Aducanumab over 100 weeks of treatment, and the drug's impact on conitive functioning.

Recruiting: No

Links and Publications: Study details are available on clinicaltrials.gov.