A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Suven Life Sciences Limited

Summary

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.

Description

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.

Eligibility

Age range: 50–90 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. * Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders. * Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE). Exclusion Criteria: * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia) * Has symptoms of agitation that are not secondary to…

Interventions

Drug
Masupirdine 50 mg
Tablet, Once Daily
Drug
Masupirdine 100 mg
Tablet, Once Daily
Drug
Placebo
Matching Placebo Tablet, Once Daily

Locations (44)

Advanced Research Center, Inc.
Anaheim, California
ATP Clinical Research, Inc.
Costa Mesa, California
Leading Edge Research LA, LLC
Encino, California
Neuro Pain Medical Center
Fresno, California
Neurology Center of North Orange County
Fullerton, California
Mary S Easton Center for Alzheimer's Research and Care UCLA
Los Angeles, California