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
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
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and
 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be
 included.
Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or
 17-AVP-786-305.

 Participants will be enrolled in the study for approximately 56 weeks (participants who have
 a follow-up visit 3 months after the last dose of treatment will be enrolled for
 approximately 64 weeks).

 Approximately 1000 participants will be enrolled at approximately 250 centers globally.

 All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to
 the participant, investigator, study staff, and the sponsor.
Inclusion Criteria:

 -  Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302,
 12-AVR-131, or 17-AVP-786-305.

 -  Participants from Study 12-AVR-131 with a diagnosis of probable AD according to the
 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group
 criteria

 -  Either out-patients or residents of an assisted-living facility or a skilled nursing
 home

 -  Participants from Study 12-AVR-131 who have clinically significant, moderate/severe
 agitation at least 2 weeks prior to baseline

 -  Participants from Study 12-AVR-131 with a diagnosis of agitation that must meet the
 International Psychogeriatric Association (IPA) provisional definition of agitation

 -  Participants from Study 12-AVR-131 with a Clinical Global Impression of Severity of
 Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and
 baseline

 -  Participants from Study 12-AVR-131 with 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 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)

 -  Participants determined to have a high imminent risk of falls during the study based
 on a clinical evaluation by the investigator

 -  Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding
 baseline