Study to Assess the Treatment of Symptoms of Agitation in Patients with Alzheimer's Disease
Purpose
Agitated behaviors such as physical and verbal aggression, pacing and wandering, are common in Alzheimer's disease and can impact the patient and caregiver's life. AVP-923 is an experimental drug being developed by Avanir Pharmaceuticals for the treatment of agitation in people with Alzheimer's disease. This study will help determine if AVP-923 is a safe and effective treatment for the symptoms of agitation in people with Alzheimer's disease. This study will randomly assign participants to take AVP-923 or matching placebo for about two and a half months. This study will require participants to travel to the study site for 8 times of the course of 12 weeks. Participants currently taking medication for agitation related to Alzheimer's disease will be allowed to continue taking medication Alzheimer's disease while participating in this study. Changes to these medications are not permitted during the study. For more information, please call the UCLA Easton Alzheimer's Disease Center at (310) 794-6039 or This email address is being protected from spambots. You need JavaScript enabled to view it. .
| Sponsor: | Avanir Pharmaceuticals |
| Collaborator: | Avanir Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01584440 |
| Condition: | Intervention: | Phase: |
| Agitation Alzheimer's Disease | Drug: AVP-923 (dextromethorphan/quinidine) | Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease. |
| Length of Study: | 12 Weeks |
Eligibility
| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
| Diagnosis of probable Alzheimer's disease (AD). |
| The patient has clinically significant symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator. |
| Either out-patients or residents of an assisted-living facility or a skilled nursing home. |
| CGI-S score is = 4 (moderately ill) at screening and baseline. |
| Mini Mental State Examination (MMSE) score at screening between 8 and 24(inclusive). |
| Caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. Caregiver must spend time with the patient a minimum of 3 times per week on 3 separate days. |
Exclusion Criteria:
| Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia). |
| Patients 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, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease). |
| Patients with myasthenia gravis. |
Contact: Doug Hawkins at (310) 794-6039 This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.