NCT03226522

Addressing Dementia Via Agitation-Centered Evaluation

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AXS-05	AXS-05
DRUG	Bupropion	Bupropion
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-07-13
• Primary completion: 2020-04-17
• Completion: 2020-04-17
• First posted: 2017-07-21
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

78 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study