ADVANCE

CompletedPhase 2 / PHASE3Results posted

Addressing Dementia Via Agitation-Centered Evaluation

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Lead sponsor

Axsome Therapeutics, Inc.

Assets

AXS-05 / Bupropion

Listed sites

Recruiting sites

Enrollment

366

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•CMAI Total Score

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-301

NCT IDNCT03226522

Timeline

Milestones

Study start2017-07-13actual

Study first posted2017-07-21actual

Primary completion2020-04-17actual

Study completion2020-04-17actual

Last update posted2023-09-13actual

Results first posted2023-09-13actual

Assets

Drug assets

AXS-05 Bupropion

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

Key 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 signification 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 (2)

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

2 endpoints

Primary/protocol endpoint

Change in CMAI Total Score

Time frame:5 weeks

change from baseline, improvement

Primary/registry result

Change in CMAI Total Score

Time frame:5 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
AXS-05n=152 Participants	-15.4	1.25
Bupropionn=49 Participants	-10.0	3.02
Placebon=156 Participants	-11.5	1.10

p0.010Mixed Models Analysis

p<0.001Mixed Models Analysis

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.