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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04797715
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : January 14, 2022
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

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
Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation,Psychomotor Drug: AXS-05 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 31, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Time from randomization to relapse of agitation symptoms [ Time Frame: up to 26 weeks ]

Other Outcome Measures:
  1. Types and rates of adverse events [ Time Frame: up to 35 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04797715

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Contact: Study Director 212-332-3223

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Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc. Identifier: NCT04797715    
Other Study ID Numbers: AXS-05-AD-302
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
NMDA receptor antagonist
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations