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Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

Primary Purpose

Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AXS-05
Bupropion
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation in Patients With Dementia of the Alzheimer's Type

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Axsome Study Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

AXS-05

Bupropion

Placebo

Arm Description

AXS-05 tablets taken by mouth for 5 weeks.

Bupropion tablets taken by mouth for 5 weeks.

Placebo tablets taken by mouth for 5 weeks.

Outcomes

Primary Outcome Measures

Change in CMAI Total Score
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).

Secondary Outcome Measures

Full Information

First Posted
July 20, 2017
Last Updated
August 22, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03226522
Brief Title
Addressing Dementia Via Agitation-Centered Evaluation
Acronym
ADVANCE
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
April 17, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Description
AXS-05 tablets taken by mouth for 5 weeks.
Arm Title
Bupropion
Arm Type
Active Comparator
Arm Description
Bupropion tablets taken by mouth for 5 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets taken by mouth for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
AXS-05
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
Bupropion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in CMAI Total Score
Description
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Axsome Study Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Axsome Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Axsome study site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Axsome study site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Axsome Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Axsome Study Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Axsome study site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Axsome study site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Axsome study site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Axsome study site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Axsome study site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Axsome Study Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Axsome study site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Axsome study site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Axsome study site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Axsome Study Site
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Axsome study site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Axsome study site
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Axsome study site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Axsome study site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Axsome Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Axsome study site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Axsome study site
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Axsome Study Site
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Facility Name
Axsome study site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Axsome study site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Axsome Study Site
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33066
Country
United States
Facility Name
Axsome Study Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Axsome study site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Axsome study site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Axsome Study Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Axsome study site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Axsome study site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Axsome Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Axsome study site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Axsome Study Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Axsome study site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Axsome study site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Axsome study site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Axsome study site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Axsome study site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Axsome Study Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Axsome study site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Axsome Study Site
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Axsome study site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Axsome Study Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Axsome Study Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Axsome study site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Axsome Study Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Axsome Study Site
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Axsome study site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Axsome Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Axsome study site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Axsome Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Axsome Study Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Axsome study site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Axsome Study Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Axsome study site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Axsome study site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Axsome study site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Axsome study site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Axsome Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Axsome study site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Axsome Study Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Axsome study site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Axsome Study Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Axsome study site
City
Shaker Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Axsome Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Axsome study site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Axsome Study Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Axsome study site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Axsome study site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Axsome Study Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Axsome Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Axsome study site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Axsome Study Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Axsome study site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Axsome study site
City
Caulfield
State/Province
Melbourne, Victoria
ZIP/Postal Code
3162
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

Addressing Dementia Via Agitation-Centered Evaluation

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