An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

The study will enroll at least 75 subjects to receive a single film consisting of BXCL501 40 μg dose, BXCL501 60 μg dose, or matching placebo film. Subjects must reside in a residential care facility and must require at least moderate assistance with activities of daily living (e.g., bathing, dressing, and toileting). The subject must be able to self-administer the film to participate in the study. The effects of BXCL 501 on acute agitation will be assessed by the following scales: PEC, PAS, ACES, and CGI-I.