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Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

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ClinicalTrials.gov Identifier: NCT03226522
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

July 20, 2017
July 21, 2017
June 25, 2018
July 13, 2017
August 2019   (Final data collection date for primary outcome measure)
Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]
Change from Baseline to Week 5 in the CMAI
Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]
Change from Baseline to Week 5 in the CMAI total score
Complete list of historical versions of study NCT03226522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Agitation in Patients With Dementia of the Alzheimer's Type
  • Alzheimer Disease
  • Agitation,Psychomotor
  • Drug: AXS-05
    AXS-05
  • Drug: Bupropion
    Bupropion
  • Drug: Placebo
    Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
435
Same as current
September 2019
August 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years to 90 Years   (Older Adult)
No
Contact: Axsome Clinical Trials +1 (212) 332-3241 ADVANCE-1@axsome.com
United States
 
 
NCT03226522
AXS-05-AD-301
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc.
Not Provided
Not Provided
Axsome Therapeutics, Inc.
June 2018

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