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

Inclusion Criteria:

• Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delaysassociated with COVID-19 restrictions.)

• Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groupcriteria

• Either out-patients or residents of an assisted-living facility or a skilled nursinghome

• Participants who delay enrollment must have clinically significant, moderate/severeagitation at least 2 weeks prior to baseline

• Participants who delay enrollment must have a diagnosis of agitation that must meetthe International Psychogeriatric Association (IPA) provisional definition ofagitation

• Participants who delay enrollment must have a Clinical Global Impression of Severityof Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening andbaseline

• Participants who delay enrollment must have a Mini-Mental State Examination (MMSE)score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

• 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)

• Participants determined to have a high imminent risk of falls during the study basedon a clinical evaluation by the investigator

• Participants who are currently using or were on NUEDEXTA® in the 2 weeks precedingbaseline