Mild-to-Moderate Alzheimer’s Disease (MINDSET)
A global, international, multi-center, randomized, double-blind, placebo-controlled Phase 3 study, MINDSET is designed to evaluate the safety, tolerability, and efficacy of intepirdine in subjects with mild to moderate Alzheimer’s disease. Intepirdine is being studied as an add-on therapy to donepezil over 24 weeks.
The trial is comparing 35 mg, once-daily oral doses of intepirdine to placebo in 1,315 subjects 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 has been used as endpoints to obtain regulatory approval of currently marketed Alzheimer’s disease treatments in the United States and Europe. All subjects who complete MINDSET are eligible to enroll in a one-year open-label extension study, in which all subjects will receive intepirdine.
- Alzheimer's disease
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