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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03226522




Registration number
NCT03226522
Ethics application status
Date submitted
20/07/2017
Date registered
21/07/2017
Date last updated
13/09/2023

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
Change in CMAI Total Score
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2020
Sample size
Target
Accrual to date
Final
366
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
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Kansas
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Louisiana
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Mississippi
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Missouri
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Texas
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Utah
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Virginia
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United States of America
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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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03226522