Assessing Clinical Outcomes in Alzheimer's Disease Agitation (ACCORD)

November 27, 2023 updated by: Axsome Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Clinical Research Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y G8
        • Clinical Research Site
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Clinical Research Site
      • Tucson, Arizona, United States, 85710
        • Clinical Research Site
    • California
      • Chula Vista, California, United States, 91910
        • Clinical Research Site
      • Imperial, California, United States, 92251
        • Clinical Research Site
      • Lafayette, California, United States, 94549
        • Clinical Research Site
      • Los Alamitos, California, United States, 90720
        • Clinical Research Site
      • Los Angeles, California, United States, 90064
        • Clinical Research Site
      • Oceanside, California, United States, 92056
        • Clinical Research Site
      • San Diego, California, United States, 92103
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
      • Temecula, California, United States, 92591
        • Clinical Research Site
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Clinical Research Site
      • Hialeah, Florida, United States, 33012
        • Clinical Research Site
      • Kissimmee, Florida, United States, 34741
        • Clinical Research Site
      • Lake City, Florida, United States, 32055
        • Clinical Research Site
      • Miami, Florida, United States, 33155
        • Clinical Research Site
      • Miami, Florida, United States, 33175
        • Clinical Research Site
      • Miami, Florida, United States, 48532
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33014
        • Clinical Research Site
      • Naples, Florida, United States, 34105
        • Clinical Research Site
      • Ocoee, Florida, United States, 34761
        • Clinical Research Site
      • Orlando, Florida, United States, 32807
        • Clinical Research Site
      • Orlando, Florida, United States, 32819
        • Clinical Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Clinical Research Site
      • Pensacola, Florida, United States, 32502
        • Clinical Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Clinical Research Site
      • Sunrise, Florida, United States, 33351
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Clinical Research Site
      • Trinity, Florida, United States, 34655
        • Clinical Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Clinical Research Site
      • Columbus, Georgia, United States, 31909
        • Clinical Research Site
      • Suwanee, Georgia, United States, 30024
        • Clinical Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 92103
        • Clinical Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Clinical Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Clinical Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Clinical Research Site
    • Massachusetts
      • Lowell, Massachusetts, United States, 01852
        • Clinical Research Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Clinical Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Clinical Research Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Clinical Research Site
      • East Syracuse, New York, United States, 13057
        • Clinical Research Site
      • New Windsor, New York, United States, 12553
        • Clinical Research Site
      • New York, New York, United States, 10036
        • Clinical Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Research Site
      • Hickory, North Carolina, United States, 28601
        • Clinical Research Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Clinical Research Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Clinical Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78737
        • Clinical Research Site
      • Cypress, Texas, United States, 77429
        • Clinical Research Site
      • Houston, Texas, United States, 77074
        • Clinical Research Site
      • McKinney, Texas, United States, 75071
        • Clinical Research Site
      • Mesquite, Texas, United States, 75149
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
      • Sugar Land, Texas, United States, 77479
        • Clinical Research Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Clinical Research Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Clinical Research Site
    • Washington
      • Everett, Washington, United States, 98201
        • Clinical Research Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 86 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time from randomization to relapse of agitation symptoms
Time Frame: up to 26 weeks
up to 26 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Types and rates of adverse events
Time Frame: up to 35 weeks
up to 35 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AXS-05-AD-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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