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A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2)

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AXS-05
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 focused on measuring AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ADVANCE-2

Eligibility Criteria

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

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 significant 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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-05

Placebo

Arm Description

Up to 5 weeks

Up to 5 weeks

Outcomes

Primary Outcome Measures

Cohen-Mansfield Agitation Inventory (CMAI)

Secondary Outcome Measures

Full Information

First Posted
September 23, 2022
Last Updated
September 21, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05557409
Brief Title
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
Acronym
ADVANCE-2
Official Title
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

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 trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
Detailed Description
Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

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
Keywords
AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ADVANCE-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Description
Up to 5 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Up to 5 weeks
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
AXS-05 tablets, taken twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, taken twice daily
Primary Outcome Measure Information:
Title
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame
Up to 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
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 significant 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
212-332-5061
Email
ADVANCE-2@axsome.com
Facility Information:
Facility Name
Clinical Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://alzheimers-study.com
Description
ADVANCE-2 Study Website
URL
http://axsome.com/
Description
Axsome Therapeutics Website

Learn more about this trial

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

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