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Trial record 2 of 12 for:    Axsome

Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226522
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE July 13, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]
Change from Baseline to Week 5 in the CMAI
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]
Change from Baseline to Week 5 in the CMAI total score
Change History Complete list of historical versions of study NCT03226522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addressing Dementia Via Agitation-Centered Evaluation
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Agitation in Patients With Dementia of the Alzheimer's Type
  • Alzheimer Disease
  • Agitation,Psychomotor
Intervention  ICMJE
  • Drug: AXS-05
    AXS-05
  • Drug: Bupropion
    Bupropion
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: AXS-05
    AXS-05 tablets taken by mouth for 5 weeks.
    Intervention: Drug: AXS-05
  • Active Comparator: Bupropion
    Bupropion tablets taken by mouth for 5 weeks.
    Intervention: Drug: Bupropion
  • Placebo Comparator: Placebo
    Placebo tablets taken by mouth for 5 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2017)
435
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Axsome Clinical Trials +1 (212) 332-3241 ADVANCE-1@axsome.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03226522
Other Study ID Numbers  ICMJE AXS-05-AD-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP