A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy 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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

时间窗: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.

Number of Participants With Serious TEAE

时间窗: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.

Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

时间窗: Baseline (current study) up to 52 weeks

Laboratory assessments included clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, cholesterol, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, protein, potassium, sodium, triglycerides and uric acid), hematology (basophils, eosinophils/leukocytes, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils/leukocytes, platelets). Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in statistical analysis plan (SAP). The categories with at least one participant with potentially clinically significant laboratory values are reported.

Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities

时间窗: Baseline (current study) up to 52 weeks

A resting 12-lead ECG was performed for all the participants. ECG data included PR interval (milliseconds {msec}) and QTcF (msec) along with change from baseline in QTcF. Number of participants with potentially clinically significant ECG abnormalities was reported as per the criteria defined in SAP.

Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding

时间窗: Baseline (current study), Week 52

The physical examination included assessments of head, eyes, ears, nose, throat, lymph nodes, skin, extremities, respiratory, gastrointestinal, musculoskeletal, cardiovascular, and nervous systems. The neurological examination included assessments of mental status, cranial nerves, motor system, reflexes, coordination, gait and station, and sensory system.

Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs

时间窗: Baseline (current study) up to 52 weeks

Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 5 and 3 minutes, respectively. Number of participants with clinically significant vital sign abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically significant vital signs abnormalities are reported here.

Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64

时间窗: Baseline (current study), Week 64

The S-STS is a prospective scale that assesses treatment-emergent suicidal thoughts and behaviors. This is a 20-item scale where each item (except item 17) of the S-STS is scored on a 5-point Likert scale as: 0 = Not at all, 1 = A little, 2 = Moderate, 3 = Very, 4 = Extremely. The S-STS total score is calculated by the sum of items 1a (if present), items 2-11, highest score of item 12 or 16, highest score of item 14 or 15, item 17 and 20. The total score ranges from 0 to 156 (If response to S-STS item 17 =yes, a score of 100 was added to the S-STS total score). Higher scores indicate greater severity of suicidal ideation and/or behavior. A negative change from baseline reflects a reduction in suicidal thoughts or behaviors over time.

Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52

时间窗: Baseline (current study), Week 52

The MMSE is a brief questionnaire that is used to assess cognitive impairment and severity of cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate a participant's cognitive state and are scored as follows: Orientation to Time - 0 to 5; Orientation to Place - 0 to 5; Registration - 0 to 3; Attention and Calculation - 0 to 5; Recall - 0 to 3; Naming - 0 to 2; Repetition - 0 to 1; Comprehension - 0 to 3; Reading - 0 to 1; Writing - 0 to 1; Drawing - 0 to 1. The total score was calculated by summing all of the item scores and ranges from 0 to 30. Higher scores indicate milder cognitive impairment. Negative change from baseline indicates decline in cognitive performance.

Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52

时间窗: Baseline (current study), Week 52

The ESS is an 8-item questionnaire that is used to measure sleepiness by rating the probability of falling asleep on 8 different situations that most people engage in during the day. The 8 questions are rated on a 4-point scale (0 to 3) where 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. The scores are summed to give an overall score of 0 to 24. A total score of 0 to 9 is considered to be normal. Higher score indicates greater daytime sleepiness. Negative change from baseline indicate improvement in daytime sleepiness.