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

Eligible participants for this study must have a diagnosis of probable AD and must have
clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of
treatment.

Approximately 470 participants will be enrolled at approximately 75 centers in North America.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening
will occur within approximately 4 weeks prior to randomization. Following screening
procedures for assessment of inclusion and exclusion criteria, eligible participants will be
randomized into the study.

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.

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 controlled hypertension, unstable
pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated
cardiomyopathy, or unstable valvular heart disease)

- Participant with myasthenia gravis