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
Sponsor: |
Avanir |
Enrolling: |
Male and Female Patients |
IRB Number: |
7180 |
U.S. Govt. ID: |
NCT02442765 |
Contact: |
Devangere Devanand: 646-774-8658 / dpd3@columbia.edu |
The objectives of the study are to evaluate the effectiveness, safety, and tolerability of study drug AVP-786 compared to placebo (contains no active medication), for the treatment of agitation in patients with dementia of the Alzheimers type. Eligible patients will be randomly assigned at the Baseline visit to receive AVP-786 or matching placebo. Study medication will be administered orally twice daily from Day 1 through Day 85. Patients (or caregivers) will self-administer study medication on all study days except on the clinic-visit days when patients will be administered their morning dose of study medication at the clinic in the presence of site personnel, regardless of the time of day. Patients will have at least a 50% chance of receiving AVP-786 at some point during the study.
This study is closed
Investigator
Davangere Devanand, MD
Have you been diagnosed with Alzheimer's Disease (AD)? |
Yes |
No |