{"id":4707,"date":"2021-04-20T15:52:30","date_gmt":"2021-04-20T22:52:30","guid":{"rendered":"https:\/\/www.iths.org\/participate\/?p=4707"},"modified":"2021-04-22T11:31:50","modified_gmt":"2021-04-22T18:31:50","slug":"avp-786-agitation","status":"publish","type":"post","link":"https:\/\/www.iths.org\/participate\/avp-786-agitation\/","title":{"rendered":"AVP-786 Agitation"},"content":{"rendered":"<div class='box summary'><\/div>\n<p>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&#039;s type<br \/>\nTo evaluate the effects of AVP-786 compared to placebo on neuropsychiatric symptoms<br \/>\nTo evaluate the effects of AVP-786 compared to placebo on global assessments of severity and improvement of agitation<br \/>\nTo evaluate the effects of AVP-786 compared to placebo on measures of quality of life and resource utilization<\/p>\n<p>This is a Phase 3 study<\/p>\n<h3>Participant Eligibility<\/h3>\n<p>Males and females 50 to 90 years of age inclusive, at the time of informed consent<br \/>\nDiagnosis of probable AD<br \/>\nOut patients or residents of assisted living facility can apply<br \/>\nHas a diagnosis of agitation<br \/>\nAgitation that interferes with daily routine <br \/>\nParticipants must have stable cardiac, pulmonary, hepatic, and renal function<br \/>\nMust have a caregiver that is willing to comply with study instructions<br \/>\nParticipant has dementia that is NOT from Parkinson&#039;s disease, substance induced, vascular, or frontotemporal types<\/p>\n<h3>Contact<\/h3>\n<p>enroll<br \/>\n(425) 453-0404<\/p>\n<div class=\"box \"><\/p>\n<h3 class=\"dets\">Additional Study Details<\/h3>\n<p><span class=\"st\"><strong>Full Study Title<\/strong><br \/>\nA Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide &#091;d6-DM&#093;\/quinidine sulfate &#091;Q&#093;) for the treatment of agitation in patients with dementia of the Alzheimer&#8217;s type<br \/>\n<\/span><\/p>\n<div class=\"lhalf sid\"><strong>Study ID:<\/strong> SSU00105289<\/div>\n<div class=\"rhalf ctlink\"><strong>ClinicalTrials.gov Link:<\/strong> <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/record\/NCT03393520\" target=\"_blank\" class=\"link-outbound\" rel=\"noopener noreferrer\">NCT03393520<\/a><\/div>\n<div class=\"clear\"><\/div>\n<div class=\"lhalf start\"><strong>Start Date:<\/strong> 10\/13\/2017<\/div>\n<div class=\"rhalf end\"><strong>End Date:<\/strong> 07\/31\/2022<\/div>\n<div class=\"clear\"><\/div>\n<p><span class=\"pi\"><strong>Investigator(s)<\/strong><br \/>\nArifulla Khan<br \/>\n<\/span><br \/>\n<span class=\"healthy\"><strong>Accepts Healthy Volunteers?<\/strong><br \/>\nNo<\/span><\/p>\n<p><strong class=\"ssites\">Study Site(s)<\/strong> <\/p>\n<div class=\"lhalf site1\">\n<h4>Northwest Clinical Research Center<\/h4>\n<p>1951 152nd Pl NE Suite 200<br \/>\nBellevue, Washington 98007<\/p><\/div>\n<div class=\"rhalf site2\">\n<h4><\/h4>\n<\/p><\/div>\n<div class=\"clear\"><\/div>\n<p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>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&#039;s type To evaluate the effects of AVP-786 compared to placebo on neuropsychiatric symptoms To evaluate the effects of AVP-786 compared to&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5,17],"tags":[1225,127,1222,129,1223,1224],"class_list":["post-4707","post","type-post","status-publish","format-standard","hentry","category-brain-and-nervous-system","category-mental-health-and-behavior","tag-agitation","tag-alzheimers","tag-brain-disease","tag-dementia","tag-mental-disorders","tag-neurodegenerative-diseases"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/4707","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/comments?post=4707"}],"version-history":[{"count":1,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/4707\/revisions"}],"predecessor-version":[{"id":4708,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/4707\/revisions\/4708"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/media?parent=4707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/categories?post=4707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/tags?post=4707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}