Addressing Dementia Via Agitation-Centered Evaluation

Summary

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.

Timeline

Start

2017-07-13

Primary completion

2020-04-17

Completion

2020-04-17

Outcome

Met primary endpoint

registry analysis (superiority test); AXS-05 vs Placebo; p = 0.010; Mixed Models Analysis NCT03226522 ↗

release “today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint in the ADVANCE-1 Phase 2/3 trial” gcs-web.com ↗

release “In this study, AXS-05 met the primary endpoint by rapidly, substantially, and statistically significantly improving agitation in patients with AD as compared to placebo.” gcs-web.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AXS-05	Unknown	—	Oral
Comparator	Bupropion	Small molecule	—	Oral

Indications