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

NCT ID: NCT05557409

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2024-12-21

Brief Summary

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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 Alzheimer's disease.

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Detailed Description

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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AXS-05

Up to 5 weeks

Group Type EXPERIMENTAL

AXS-05

Intervention Type DRUG

AXS-05 tablets, taken twice daily

Placebo

Up to 5 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, taken twice daily

Interventions

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AXS-05

AXS-05 tablets, taken twice daily

Intervention Type DRUG

Placebo

Placebo tablets, taken twice daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Peoria, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Canoga Park, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Walnut Creek, California, United States

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West Covina, California, United States

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Bonita Springs, Florida, United States

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Brandon, Florida, United States

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Greenacres City, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Gardens, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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College Park, Georgia, United States

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Columbus, Georgia, United States

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Wichita, Kansas, United States

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Marrero, Louisiana, United States

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Braintree, Massachusetts, United States

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Flint, Michigan, United States

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Rochester Hills, Michigan, United States

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Troy, Michigan, United States

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Chesterfield, Missouri, United States

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Berlin, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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New Windsor, New York, United States

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Staten Island, New York, United States

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Woodmere, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Austin, Texas, United States

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Cypress, Texas, United States

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Mesquite, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Rutland, Vermont, United States

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Arlington, Virginia, United States

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Bayamón, , Puerto Rico

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Clinical Research Site

San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

Related Links

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http://axsome.com/

Axsome Therapeutics Website

Other Identifiers

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AXS-05-AD-304

Identifier Type: -

Identifier Source: org_study_id

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