Addressing Dementia Via Agitation-Centered Evaluation

Phase 2

Completed

• Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Agitation,Psychomotor; Alzheimer Disease
• Interventions: Drug: Placebo; Drug: AXS-05; Drug: Bupropion

• Registration Number: NCT03226522
• Lead Sponsor: Axsome Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Primary Completion: 2020-04-17
• Study Completion: 2020-04-17
• Results First Submitted: 2023-02-14
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets taken by mouth for 5 weeks.
AXS-05	AXS-05	AXS-05 tablets taken by mouth for 5 weeks.
Bupropion	Bupropion	Bupropion tablets taken by mouth for 5 weeks.

Primary Outcome Measures

Name	Time	Method
Change in CMAI Total Score	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).

Trial Locations

Locations (2)

Axsome study site; 🇦🇺 Caulfield, Melbourne, Victoria, Australia

Axsome Study Site; 🇺🇸 Everett, Washington, United States