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Further Analyses Of The Safety Of Verubecestat In The Phase 3 Epoch Trial Of Mild-To-Moderate Alzheimer’S Disease, Michael F. Egan, Yuki Mukai, Tiffini Voss, James Kost, Julie Stone, Christine Furtek, Erin Mahoney, Jeffrey L. Cummings, Pierre N. Tariot, Paul S. Aisen, Bruno Vellas, Christopher Lines, David Michaelson

Integrated Health Sciences Faculty Publications

Background: Verubecestat, a BACE1 inhibitor that reduces Aβ levels in the cerebrospinal fluid of humans, was not effective in a phase 3 trial (EPOCH) of mild-to-moderate AD and was associated with adverse events. To assist in the development of BACE1 inhibitors, we report detailed safety findings from EPOCH. Methods: EPOCH was a randomized, double-blind, placebo-controlled 78-week trial evaluating verubecestat 12 mg and 40 mg in participants with mild-to-moderate AD diagnosed clinically. The trial was terminated due to futility close to its scheduled completion. Of 1957 participants who were randomized and took treatment, 652 were assigned to verubecestat 12 mg, 652 …