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.