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

Agitation in Patients With Dementia of the Alzheimer's Type Clinical Trial

Official title: A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy 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

Status Recruiting

Clinical Trial Summary

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Clinical Trial Description

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks). Approximately 1200 participants will be enrolled at approximately 250 centers globally. All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor. ;

Related Conditions & MeSH terms

• Agitation in Patients With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

• NCT number: NCT02446132
• 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: December 2015
• Completion date: January 30, 2025