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ACCORD: Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04797715
Collaborator
(none)
260
Enrollment
60
Locations
2
Arms
23
Anticipated Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Placebo-controlled, Randomized Withdrawal 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 :
Dec 31, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AXS-05

Up to 26 weeks in double-blind period

Drug: AXS-05
AXS-05 tablets, taken twice daily
Placebo Comparator: Placebo

Up to 26 weeks in double-blind period

Drug: Placebo
Placebo tablets, taken twice daily

Outcome Measures

Primary Outcome Measures

  1. Time from randomization to relapse of agitation symptoms [up to 26 weeks]

Other Outcome Measures

  1. Types and rates of adverse events [up to 35 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Site Sun City Arizona United States 85351
2 Clinical Research Site Tucson Arizona United States 85710
3 Clinical Research Site Chula Vista California United States 91910
4 Clinical Research Site Imperial California United States 92251
5 Clinical Research Site Lafayette California United States 94549
6 Clinical Research Site Los Alamitos California United States 90720
7 Clinical Research Site Los Angeles California United States 90064
8 Clinical Research Site Oceanside California United States 92056
9 Clinical Research Site San Diego California United States 92103
10 Clinical Research Site Santa Ana California United States 92705
11 Clinical Research Site Temecula California United States 92591
12 Clinical Research Site Coral Springs Florida United States 33067
13 Clinical Research Site Hialeah Florida United States 33012
14 Clinical Research Site Kissimmee Florida United States 34741
15 Clinical Research Site Lake City Florida United States 32055
16 Clinical Research Site Miami Lakes Florida United States 33014
17 Clinical Research Site Miami Florida United States 33155
18 Clinical Research Site Miami Florida United States 33175
19 Clinical Research Site Miami Florida United States 48532
20 Clinical Research Site Naples Florida United States 34105
21 Clinical Research Site Ocoee Florida United States 34761
22 Clinical Research Site Orlando Florida United States 32807
23 Clinical Research Site Orlando Florida United States 32819
24 Clinical Research Site Pembroke Pines Florida United States 33024
25 Clinical Research Site Pensacola Florida United States 32502
26 Clinical Research Site Saint Petersburg Florida United States 33709
27 Clinical Research Site Sunrise Florida United States 33351
28 Clinical Research Site Tampa Florida United States 33634
29 Clinical Research Site Trinity Florida United States 34655
30 Clinical Research Site Columbus Georgia United States 31909
31 Clinical Research Site Suwanee Georgia United States 30024
32 Clinical Research Site Honolulu Hawaii United States 92103
33 Clinical Research Site Boise Idaho United States 83704
34 Clinical Research Site Wichita Kansas United States 67214
35 Clinical Research Site Bangor Maine United States 04401
36 Clinical Research Site Lowell Massachusetts United States 01852
37 Clinical Research Site Flint Michigan United States 48532
38 Clinical Research Site Chesterfield Missouri United States 63005
39 Clinical Research Site Las Vegas Nevada United States 89106
40 Clinical Research Site Toms River New Jersey United States 08755
41 Clinical Research Site Brooklyn New York United States 11229
42 Clinical Research Site East Syracuse New York United States 13057
43 Clinical Research Site New Windsor New York United States 12553
44 Clinical Research Site New York New York United States 10036
45 Clinical Research Site Hickory North Carolina United States 28601
46 Clinical Research Site Dayton Ohio United States 45459
47 Clinical Research Site Jenkintown Pennsylvania United States 19046
48 Clinical Research Site Philadelphia Pennsylvania United States 19104
49 Clinical Research Site Austin Texas United States 78737
50 Clinical Research Site Cypress Texas United States 77429
51 Clinical Research Site Houston Texas United States 77074
52 Clinical Research Site McKinney Texas United States 75071
53 Clinical Research Site Mesquite Texas United States 75149
54 Clinical Research Site Sugar Land Texas United States 77479
55 Clinical Research Site West Jordan Utah United States 84088
56 Clinical Research Site Woodstock Vermont United States 05091
57 Clinical Research Site Everett Washington United States 98201
58 Clinical Research Site Waukesha Wisconsin United States 53188
59 Clinical Research Site Kelowna British Columbia Canada V1Y 1Z9
60 Clinical Research Site Newmarket Ontario Canada L3Y G8

Sponsors and Collaborators

  • Axsome Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04797715
Other Study ID Numbers:
  • AXS-05-AD-302
First Posted:
Mar 15, 2021
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Axsome Therapeutics, Inc.
AD agitation
AXS-05
NMDA receptor antagonist
dextromethorphan
bupropion
Axsome
ACCORD
Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation

Study Results

No Results Posted as of May 12, 2022