MINDSET is a Phase 3 international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of intepirdine (RVT-101) in patients with mild-to-moderate Alzheimer’s disease.
The 24-week trial will compare 35 mg, once-daily oral doses of intepirdine to placebo in 1,315 patients patients with mild-to-moderate Alzheimer’s disease on a stable background of donepezil therapy. The primary efficacy evaluations are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Scale (ADCS-ADL), each of which have been used as endpoints to obtain regulatory approval of currently-marketed Alzheimer’s disease treatments in the United States and Europe.
The MINDSET Phase 3 trial is designed to confirm the results of a 684-patient international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg intepirdine demonstrated statistically significant improvements on the ADAS-cog and ADCS-ADL as compared to patients receiving donepezil alone.
A global Phase 3 clinical research study evaluating Intepirdine
(RVT-101)* for mild-to-moderate Alzheimer’s Disease
*Intepirdine (RVT-101) is an investigational new drug candidate and is not approved for any indication in any markets.
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