A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
Overview
- Phase
- Phase 3
- Intervention
- AXS-05
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Time from randomization to relapse of agitation symptoms
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Detailed Description
Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
- •Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Exclusion Criteria
- •Patient has dementia predominantly of non-Alzheimer's type.
- •Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
Arms & Interventions
AXS-05
Up to 26 weeks in double-blind period
Intervention: AXS-05
Placebo
Up to 26 weeks in double-blind period
Intervention: Placebo
Outcomes
Primary Outcomes
Time from randomization to relapse of agitation symptoms
Time Frame: up to 26 weeks