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
Overview
- Phase
- Phase 2
- Intervention
- AXS-05
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 366
- Locations
- 2
- Primary Endpoint
- Change in CMAI Total Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
Arms & Interventions
AXS-05
AXS-05 tablets taken by mouth for 5 weeks.
Intervention: AXS-05
Bupropion
Bupropion tablets taken by mouth for 5 weeks.
Intervention: Bupropion
Placebo
Placebo tablets taken by mouth for 5 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in CMAI Total Score
Time Frame: 5 weeks
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).