Speaking from a press briefing at the Alzheimer’s Association International Conference (AAIC) 2018, in Chicago, IL, Lynn Kramer, MD, of Eisai Inc., Woodcliff Lake, NJ, discusses his group’s Phase II 18-month-long trial with ~800 patients (NCT01767311). Across 5 active arms, this study compared the efficacy of 3 different doses of BAN2401, a monoclonal antibody which targets amyloid-β protofibrils, with a placebo group, in order to determine its effect on cognitive decline in early Alzheimer’s disease. This was a large, multicenter study unique in its protocol. Bayesian statistics were used to inform a response adaptive randomization of patients to the different experimental groups, and this design was combined with ADCOMS composite clinical score endpoints. In this video, Dr Kramer gives an in-depth exploration of this trial design, highlighting the key points and explaining how the complex design was implemented.
