At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 220 enrolled
Drug / intervention
AVP-923-20 +2 moredrug
Likely dose
AVP-923-20 20 mgfrom 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 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.
In Brief
A Phase 2 clinical trial evaluating AVP-923-20, Placebo, and 1 other intervention for Agitation and Alzheimer's Disease. Completed, enrolled 220 participants across 44 sites.
Detailed Summary
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation, Alzheimer's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartAug 2012
Primary CompletionJul 2014
TodayJul 2026
First PostedApr 25, 2012
Enrollment StartAug 13, 2012
Primary CompletionJul 30, 2014
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 14.2 years ago
Interventions
AVP-923-20drug
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
Placebodrug
Placebo capsule
AVP-923-30drug
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine