Merck overturns APECS Study assessing Verubecestat (MK-8931) for Prodromal Alzheimer’s Disease

Merck declared that it will rescind protocol 019 also termed as the APECS study assessing verubecestat (MK-8931), an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with prodromal Alzheimer’s disease. The discontinuation is owing to recommendation by the external Data Monitoring Committee that evaluated overall benefit/risk during a recent interim safety analysis.  The eDMC  extrapolated that it was unlikely that positive benefit/risk could be established if the trial continued.

APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase 3 clinical trial evaluating the efficacy and safety of verubecestat in people with prodromal AD. Subjects are randomized to receive placebo, or 12 mg or 40 mg verubecestat, once-daily.

Dr. Roger M. Perlmutter, president, Merck Research Laboratories said “We are grateful to the patients and caregivers who participated in this study, and despite this outcome, Merck remains committed to developing novel therapies for the treatment of Alzheimer’s and other neurodegenerative diseases.”