NCT02442778

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants 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: 522 (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) will 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 a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD. This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 470 participants will be enrolled at approximately 75 centers in North America. Study medication will be administered orally twice-daily from Day 1 through Week 12 (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 in Participants With Dementia of the Alzheimer's Type

Interventions

Type	Name	Description
DRUG	AVP-786-18	18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)
DRUG	Placebo	Administered as capsules.
DRUG	AVP-786-28	28 mg of d6-DM and 4.9 mg of Q
DRUG	AVP-786-42.63	42.63 mg of d6-DM and 4.9 mg of Q

Timeline

• Start date: 2015-11-11
• Primary completion: 2019-08-14
• Completion: 2019-09-09
• First posted: 2015-05-13
• Last updated: 2022-09-09
• Results posted: 2022-09-09

Locations

83 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study