Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Inclusion Criteria: * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria * The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation * Either out participants or residents of an assisted-living facility or a skilled nursing home * Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is \>=4 (moderately ill) at screening and baseline * Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant. Exclusion Criteria: * Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia) * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly c…