The amyloid hypothesis, which states that extracellular amyloid deposits in the brain are the fundamental cause of Alzheimer’s disease, has been supported by a few recent studies, including a Phase II trial (NCT01767311) whose results were presented in a press brief at the Alzheimer’s Association International Conference (AAIC) 2018, in Chicago, IL. In this video, Lynn Kramer, MD, of Eisai Inc., Woodcliff Lake, NJ, discusses the results of the trial, which randomly assigned 5 different regimens of BAN2401 and one placebo amongst patients with early Alzheimer’s disease using a Bayesian adaptive randomization protocol. Dr Kramer discusses the positive trial results and explains the complex statistical endpoints that were applied. The key findings of this trial were at 18 months, where the highest BAN2401 dose yielded a 47% reduction in cognitive decline and 81% of patients reached amyloid negativity. This is the largest, most complex trial to date in support of the amyloid hypothesis. Finally, Maria Grazia Spillantini, FRS, FMedSci, of the University of Cambridge, Cambridge, UK, responds to these results, emphasizing their importance in the wider landscape of Alzheimer’s research, and also highlighting other key future prospects for the field.
