Clinical-stage biopharmaceutical company, Axovant Sciences Ltd., recently announced it has screened the first batch of patients for MINDSET, an international Phase III clinical trial exploring RVT-101 as a candidate treatment for Alzheimer’s disease. The company also reported the US Food and Drug Administration’s decision to grant MINDSET a Special Protocol Assessment (SPA).
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 this final stage of the drug development process,” said Axovant Chief Development Officer Dr. Lawrence Friedhoff, who is leading the RVT-101 development program and previously led the development program for donepezil (brand name Aricept), the most widely used Alzheimer’s treatment.
“No new compounds have been approved for Alzheimer’s disease in over a decade, and physicians are scrambling to do more for their patients,” said Dr. Gary Small, President of the American Association for Geriatric Psychiatry. “We need well-tolerated, once-daily oral treatments that provide clinically meaningful benefits. The start of the MINDSET study is an important milestone for the field of Alzheimer’s drug development.”
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