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Completed

NCT Number: NCT04797715

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

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.

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Key information

Conditions

Agitation in Patients With Dementia of the Alzheimer's Type Aberrant Motor Behavior in Dementia Agitation,Psychomotor Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Tauopathies

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AXS-05

Drug

AXS-05 tablets, taken twice daily

Placebo

Drug

Placebo tablets, taken twice daily

Primary outcomes

  1. Time from randomization to relapse of agitation symptoms

    Time frame: up to 26 weeks

Other outcomes

  1. Types and rates of adverse events

    Time frame: up to 35 weeks

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: ACCORD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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