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

This trial was a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of 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 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, Bayamón, Puerto Rico

About this study

Eligible subjects were randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

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 significant 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.
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

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame: Up to 5 weeks

The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Acronym: ADVANCE-2

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 28, 2022
Registry last updated: Aug 13, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed