NCT05397639

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Agitation
• Alzheimer's Type Dementia

Interventions

Type	Name	Description
DRUG	Masupirdine 50 mg	Tablet, Once Daily
DRUG	Masupirdine 100 mg	Tablet, Once Daily
DRUG	Placebo	Matching Placebo Tablet, Once Daily

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-05-31
• Last updated: 2026-01-12

Locations

44 sites across 4 countries: United States, Croatia, Poland, Serbia

Regulatory

• FDA-regulated drug study