A Phase 3 multicenter randomized double-blind placebo-controlled study to assess the efficacy safety and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer's type

Inclusion Criteria
Diagnosis of probable AD according to the 2011 NIA-AA working group criteria. Either out-patients or residents of an assisted living facility or a skilled nursing home.
The patient has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization, that interferes with daily routine and for which a prescription medication is indicated, in the opinion of the investigator
The diagnosis of agitation must meet the IPA provisional definition of agitation
CGIS-Agitation score is greater than or equal to 4 (moderately ill) at Screening and Baseline
MMSe score is between 6 and 26 (inclusive) at Screening and Baseline
The patient has stable cardiac, pulmonary, hepatic, and renal function
The patient has an ECG (obtained within the past month prior to randomization and evaluated by a central ECG reader) with no clinically significant findings
Patient must not show current and significant symptoms of a depressive disorder and must have a score less than 10 in the Cornell Scale for Depression in Dementia (CSDD) at Screening
Patient must have no history or current clinical symptoms of schizophrenia, schizaffective disorder, or bipolar disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV_TR)
Caregiver must be willing and able to comply with study procedures, including not administering any prohibited medications during the course of the study
Exclusion Criteria
Caregiver is unwilling or unable, in the opinion of the investigator, to comply with the study instructions
Patient has dementia predominantly of non-Alzheimer's type
Patients with symptoms of agitation that are not secondary to AD
Patients with myasthenia gravis
Patients with any personal history of complete heart block, QTc prolongation, or torsades de pointes
Patients with any family history of congenital QT interval prolongation syndrome
Patients with known hypersensitivity to DM, Q, opiate drug, or any other ingredient of the study medication
Patients with history of allergy to benzodiazepines
Patients who have ever received DM co-administered with Q
Patients who have been taking disallowed concomitant medications within 2 weeks or 5 half-lives, whichever is longer, prior to Baseline
Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease
Patients who are currently participating in, or who have participated in other interventional clinical study within 30 days of Baseline
Patients with history of postural syncope, or any history of unexplained syncope within 12 months of Baseline
Patients with a history of substance and/or alcohol abuse within the past 1 year
Patients determined to have high imminent risk of falls during the study based on a clinical evaluation by the investigator
Patients with evidence of serious risk of suicide at Screening and Baseline based on the Sheehan Suicidality Tracking Scale