Phase 3 Study to Test Safety and Effectiveness of Masupirdine Tablets for Treating Agitation in Alzheimers Dementia Patients Aged 50 to 90

What this Trial Is About

Researchers are evaluating masupirdine, an oral tablet taken once daily, for its potential to treat agitation in people with dementia of the Alzheimers type. This phase 3, multicenter study is randomized, double-blind, and placebo-controlled, aiming to assess the drugs efficacy, safety, tolerability, and pharmacokinetics. About 375 participants aged 50 to 90 years will be enrolled worldwide. Participants will be randomly assigned to one of three groups low dose masupirdine 50 mg, high dose masupirdine 100 mg, or a matching placebo. Treatment will last 12 weeks, with dosing from Day 1 through Day 85. Screening will take place within approximately 4 weeks before randomization to confirm eligibility based on cognitive and agitation criteria. During the study, participants will be monitored using assessments like the Cohen-Mansfield Agitation Inventory to measure agitation changes from baseline to Week 12. Additional evaluations include the Modified Alzheimers Disease Cooperative Study-Clinical Global Impression of Change. Researchers will track safety and tolerability throughout. The total involvement spans the screening and 12-week treatment period, with ongoing monitoring for effects and side effects.

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type