Summary
This study focuses on individuals who have been diagnosed with probable Alzheimer’s disease (AD) and have agitation. Agitated behaviors such as irritability and restlessness, physical/verbal aggression, pacing and wandering are major problems in Alzheimer’s patients. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of an investigational drug called AVP-786 for the treatment of agitation in participants with dementia of the Alzheimer’s type. AVP-786 is a combination product of deudextromethorphan hydrobromide, a central nervous system-active agent, and quinidine sulfate. Participants will be randomly assigned to receive either AVP-786 or placebo.
Inclusion Criteria
- Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
- Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
- Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
- Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
Study Location(s)
Beverly
More about this Clinical Trial
Full Title
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer?s type