NCT02442765

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 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Detailed description

Eligible participants for this study must have had a diagnosis of probable AD and must have had clinically meaningful agitation secondary to AD. This was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 380 participants were to be enrolled at approximately 60 centers in North America. Study medication was to be administered orally twice-daily from Day 1 through Day 85. Screening was to occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were to be randomized into the study.

Conditions

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

Interventions

Type	Name	Description
DRUG	AVP-786
DRUG	Placebo

Timeline

• Start date: 2015-07-23
• Primary completion: 2019-01-30
• Completion: 2019-02-27
• First posted: 2015-05-13
• Last updated: 2023-02-13
• Results posted: 2023-02-13

Locations

126 sites across 6 countries: United States, Estonia, Germany, Poland, Portugal, Puerto Rico

Regulatory

• FDA-regulated drug study