Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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.

Timeline

Start

2015-07-23

Primary completion

2019-01-30

Completion

2019-02-27

Outcome

Mixed primary results

registry Stage 1: Placebo vs Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg); p =0.021; Least Squares Mean Difference -4.0 (95% CI -7.4 to -0.6) NCT02442765 ↗

registry Stage 1: Placebo vs Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg); p =0.731; Least Squares Mean Difference -0.6 (95% CI -3.9 to 2.7) NCT02442765 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deudextromethorphan	Unknown	18 mg	Oral
Subject	Deudextromethorphan	Unknown	28 mg	Oral
Subject	Quinidine	Small molecule	4.9 mg	Oral

Indications

No indication recorded.