At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 387 enrolled
Drug / intervention
AVP-786 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 13, 2015·Updated Feb 13, 2023
In Brief
A Phase 3 clinical trial evaluating AVP-786 and Placebo for Agitation in Patients With Dementia of the Alzheimer's Type. Completed, enrolled 387 participants across 126 sites in 6 countries.
Detailed Summary
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEstonia, Germany, Poland, Portugal, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJul 2015
Primary CompletionJan 2019
Study CompletionFeb 2019
TodayJul 2026
First PostedMay 13, 2015
Enrollment StartJul 23, 2015
Primary CompletionJan 30, 2019
Study CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.1 years ago
Interventions
AVP-786drug
Placebodrug