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Completed

NCT Number: NCT04947553

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

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

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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

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
  • Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion criteria

  • Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  • Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
  • Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
  • Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.

Treatment and study plan

AXS-05 (dextromethorphan-bupropion)

Drug

AXS-05 tablets, taken twice daily

Placebo

Drug

Placebo tablets, taken twice daily

Primary outcomes

  1. Long-term Safety

    Time frame: up to 76 weeks

    Incidence of treatment-emergent adverse events following dosing with AXS-05

  2. Time to relapse of agitation symptoms

    Time frame: up to 24 weeks

Other outcomes

  1. Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: up to 76 weeks

    Change from Baseline to last dose in the CMAI

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type

Acronym: ACCORD-2

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2021
Registry last updated
Dec 8, 2025

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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