Assessment of the Efficacy, Safety, and Tolerability of AVP-786 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 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 Recruiting

Clinical Trial Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) 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 study, consisting of 12 weeks of treatment.

Approximately 750 participants will be enrolled at approximately 110 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: NCT04408755
• Study type: Interventional
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: Otsuka Call Center
• Phone: 844-687-8522
• Email: OtsukaRMReconciliation@rmpdc.org
• Status: Recruiting
• Phase: Phase 3
• Start date: July 8, 2020
• Completion date: March 31, 2026