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

• Status: Completed
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Treatments: Dextromethorphan; Quinidine; Quinidine gluconate

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 patients 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