MINDSET was designed as a global, multi-center, double blind, placebo-controlled investigation that aims to evaluate RVT-101's safety, tolerability and efficacy profile in patients with mild-to-moderate Alzheimer's disease. The study will enroll 1,150 patients who will be randomized to receive either a placebo or 35 mg of the drug once a day for 24 weeks. Patients should have a stable treatment history with donepezil.Achievement of primary endpoints will be based on the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer's Disease Cooperative Study – Activities of Daily Living scale (ADCS-ADL) - two endpoint criteria that have been used extensively in past studies for today's approved medications in the US and in Europe. Positive confirmatory findings from MINDSET will give Axovant the green light to file for a New Drug Application with the FDA before the end of 2017. Findings from the MINDSET study will also serve to confirm those obtained from a previously completed study that involved 684 patients and was able to demonstrate statistically notable improvements on the ADAS-cog and ADCS-ADL, versus patients receiving donepezil alone.
"I am grateful for the unwavering efforts of the entire development team that has so rapidly advanced RVT-101 into