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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03226522|
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation,Psychomotor||Drug: AXS-05 Drug: Bupropion Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||July 13, 2017|
|Actual Primary Completion Date :||April 17, 2020|
|Actual Study Completion Date :||April 17, 2020|
AXS-05 tablets taken by mouth for 5 weeks.
Active Comparator: Bupropion
Bupropion tablets taken by mouth for 5 weeks.
Placebo Comparator: Placebo
Placebo tablets taken by mouth for 5 weeks.
- Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]Change from Baseline to Week 5 in the CMAI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226522