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Clinical Trial Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.


Clinical Trial Description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 750 participants will be enrolled at approximately 110 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04464564
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact Otsuka Call Center
Phone 844-687-8522
Email OtsukaRMReconciliation@rmpdc.org
Status Recruiting
Phase Phase 3
Start date September 3, 2020
Completion date November 30, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Completed NCT03393520 - Assessment of 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 Phase 3
Enrolling by invitation NCT04947553 - A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT04408755 - Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type Phase 3
Completed NCT02442765 - Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type Phase 3
Completed NCT03226522 - Addressing Dementia Via Agitation-Centered Evaluation Phase 2/Phase 3
Completed NCT04797715 - Assessing Clinical Outcomes in Alzheimer's Disease Agitation Phase 3
Recruiting NCT02446132 - Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type Phase 3