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
750 patients around the world
Available in United States, Colombia, Spain
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.
Otsuka Pharmaceutical Development & Commercialization, Inc.