20 Apr AVP-786 Agitation
To evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in patients with dementia of the Alzheimer's type
To evaluate the effects of AVP-786 compared to placebo on neuropsychiatric symptoms
To evaluate the effects of AVP-786 compared to placebo on global assessments of severity and improvement of agitation
To evaluate the effects of AVP-786 compared to placebo on measures of quality of life and resource utilization
This is a Phase 3 study
Participant Eligibility
Males and females 50 to 90 years of age inclusive, at the time of informed consent
Diagnosis of probable AD
Out patients or residents of assisted living facility can apply
Has a diagnosis of agitation
Agitation that interferes with daily routine
Participants must have stable cardiac, pulmonary, hepatic, and renal function
Must have a caregiver that is willing to comply with study instructions
Participant has dementia that is NOT from Parkinson's disease, substance induced, vascular, or frontotemporal types
Contact
enroll
(425) 453-0404
Additional Study Details
Full Study Title
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type
Investigator(s)
Arifulla Khan
Accepts Healthy Volunteers?
No
Study Site(s)
Northwest Clinical Research Center
1951 152nd Pl NE Suite 200
Bellevue, Washington 98007
