Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients 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 patients 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.