Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Agitation in Patients With Dementia of the Alzheimer's Type Clinical Trial

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Status Completed

Clinical Trial Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

Clinical Trial Description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.

Approximately 550 participants will be enrolled at approximately 90 centers worldwide.

Study medication will be administered orally twice-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. ;

Related Conditions & MeSH terms

• Agitation in Patients With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

• NCT number: NCT03393520
• Study type: Interventional
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2017
• Completion date: December 14, 2023