CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 522 enrolled
Drug / intervention
AVP-786-18 +3 moredrug
Likely dose
AVP-786-18 18 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.

Search/NCT02442778
NCT02442778Phase 3Completed
CompareCT.gov

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 Sep 9, 2022

In Brief

A Phase 3 clinical trial evaluating AVP-786-18, Placebo, and 2 other interventions for Agitation in Participants With Dementia of the Alzheimer's Type. Completed, enrolled 522 participants across 83 sites in 2 countries.

Detailed Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will 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--
ConditionsAgitation in Participants With Dementia of the Alzheimer's Type
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 13, 2015
Enrollment StartNov 11, 2015
Primary CompletionAug 14, 2019
Study CompletionSep 9, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

AVP-786-18drug

18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)

Placebodrug

Administered as capsules.

AVP-786-28drug

28 mg of d6-DM and 4.9 mg of Q

AVP-786-42.63drug

42.63 mg of d6-DM and 4.9 mg of Q