NCT04408755

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study was 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.

Detailed description

Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD. This was a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study. 184 participants were enrolled into the study. Study medication was administered orally twice daily from Day 1 through Day 85.

Conditions

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

Interventions

Type	Name	Description
DRUG	AVP-786	oral capsules
DRUG	Placebo	oral capsules

Timeline

• Start date: 2020-07-13
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2020-05-29
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

95 sites across 11 countries: United States, Bulgaria, Denmark, Estonia, Germany, Greece, Poland, Portugal, Puerto Rico, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study