Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Condition: Agitation in Participants With Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Intervention: AVP-786-18; Placebo; AVP-786-28; AVP-786-42.63
Intervention description: 18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q); Administered as capsules.; 28 mg of d6-DM and 4.9 mg of Q; 42.63 mg of d6-DM and 4.9 mg of Q
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 522.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
      probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for
      Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
      (AA) workgroups.
    

Eligibility criteria:

        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 participants 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