ADVANCE-2

CompletedPhase 3

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

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

Lead sponsor

Axsome Therapeutics, Inc.

Asset

AXS-05

Listed sites

Recruiting sites

Enrollment

408

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Cohen-Mansfield Agitation Inventory (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAXS-05-AD-304

NCT IDNCT05557409

Timeline

Milestones

Study start2022-09-06actual

Study first posted2022-09-28actual

Primary completion2024-11-21actual

Study completion2024-12-21actual

Last update posted2025-11-26actual

Assets

Drug assets

AXS-05

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:Up to 5 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.