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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03226522




Registration number
NCT03226522
Ethics application status
Date submitted
20/07/2017
Date registered
21/07/2017
Date last updated
28/03/2019

Titles & IDs
Public title
Addressing Dementia Via Agitation-Centered Evaluation
Scientific 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
Secondary ID [1] 0 0
AXS-05-AD-301
Universal Trial Number (UTN)
Trial acronym
ADVANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in Patients With Dementia of the Alzheimer's Type 0 0
Alzheimer Disease 0 0
Agitation,Psychomotor 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AXS-05
Treatment: Drugs - Bupropion
Treatment: Drugs - Placebo

Experimental: AXS-05 - 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.


Treatment: Drugs: AXS-05
AXS-05

Treatment: Drugs: Bupropion
Bupropion

Treatment: Drugs: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohen-Mansfield Agitation Inventory (CMAI) - Change from Baseline to Week 5 in the CMAI
Timepoint [1] 0 0
5 weeks

Eligibility
Key inclusion criteria
Key

- 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.
Minimum age
65 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Melbourne, VIC
Recruitment hospital [1] 0 0
Axsome study site - Caulfield
Recruitment postcode(s) [1] 0 0
3162 - Caulfield
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Axsome Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03226522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Axsome Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+1 (212) 332-3241
Fax 0 0
Email 0 0
ADVANCE-1@axsome.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03226522