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 NationalInstitute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
• The participant has clinically significant, moderate/severe agitation at the time ofscreening 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 skillednursing 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) atscreening and baseline
• Caregiver who is able and willing to comply with all required study procedures. Inorder to qualify as a reliable informant (i.e., caregiver) capable of assessingchanges in participant's condition during the study, the individual must spend aminimum 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., vasculardementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
• Participants with co-existent clinically significant or unstable systemic diseasesthat could confound the interpretation of the safety results of the study (e.g.,malignancy, poorly controlled diabetes, poorly controlled hypertension, unstablepulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilatedcardiomyopathy, or unstable valvular heart disease)
• Participant with myasthenia gravis