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COMPLETEDPhase 3NCT05557409

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

This trial is 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 Alzhei...

Lead sponsor: Axsome Therapeutics, Inc.•53 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Axsome Therapeutics, Inc.

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

Age

65 - 90 years

Sex

ALL

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 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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 26, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment408

Start dateSep 2022

Last updatedNov 26, 2025

Condition

Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation

Locations shown

Clinical Research Site

Peoria, Arizona

Clinical Research Site

Tempe, Arizona

Clinical Research Site

Tucson, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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