This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.~Approximately 375 participants will be enrolled at approximately 50 centers worldwide.~Study medication will be administered orally once-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.