Agitation in Patients With Dementia of the Alzheimer's TypePhase 3ADVANCE-2NCT05557409

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

A Phase 3 study testing AXS-05 in people with Agitation in Patients With Dementia of the Alzheimer's Type and Alzheimer Disease, run by Axsome Therapeutics, Inc. at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 65 to 90 years
Conditions the study is for: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
What is being tested?: AXS-05
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 408 participants
Where: 55 sitesin 2 countries
Study dates: 6 Sep 2022to 21 Dec 2024
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 90 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

55 sites in 2 countries.

Country

City, postcode or hospital

55 sites in 2 countries

United States53 sites

Clinical Research Site
Arlington, Virginia, 22205
Clinical Research Site
Augusta, Georgia, 30912
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Berlin, New Jersey, 08009
Clinical Research Site
Bonita Springs, Florida, 34134
Clinical Research Site
Braintree, Massachusetts, 02184
Clinical Research Site
Brandon, Florida, 33511
Clinical Research Site
Brooklyn, New York, 11229
Clinical Research Site
Canoga Park, California, 91303
Clinical Research Site
Charlotte, North Carolina, 28211
Clinical Research Site
Chesterfield, Missouri, 63005
Clinical Research Site
College Park, Georgia, 30349
Clinical Research Site
Columbus, Georgia, 31909
Clinical Research Site
Cypress, Texas, 77429
Clinical Research Site
Flint, Michigan, 48532
Clinical Research Site
Green Acres, Florida, 33467
Clinical Research Site
Hialeah, Florida, 33012
Clinical Research Site
Hickory, North Carolina, 28601
Clinical Research Site
Hollywood, Florida, 33024
Clinical Research Site
Kissimmee, Florida, 34741
Clinical Research Site
Long Beach, California, 90807
Clinical Research Site
Los Alamitos, California, 90720
Clinical Research Site
Marrero, Louisiana, 70072
Clinical Research Site
Mesquite, Texas, 75149
Clinical Research Site
Miami, Florida, 33126
Clinical Research Site
Miami, Florida, 33135
Clinical Research Site
Miami, Florida, 33145
Clinical Research Site
Miami, Florida, 33155
Clinical Research Site
Miami, Florida, 33165
Clinical Research Site
Miami, Florida, 33173
Clinical Research Site
Miami, Florida, 33175
Clinical Research Site
Miami Gardens, Florida, 33014
Clinical Research Site
Miami Lakes, Florida, 33014
Clinical Research Site
Middleburg Heights, Ohio, 44130
Clinical Research Site
New Windsor, New York, 12553
Clinical Research Site
Orlando, Florida, 32807
Clinical Research Site
Pembroke Pines, Florida, 33025
Clinical Research Site
Peoria, Arizona, 85381
Clinical Research Site
Rochester Hills, Michigan, 48307
Clinical Research Site
Rutland, Vermont, 05701
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
Staten Island, New York, 10314
Clinical Research Site
Sugarland, Texas, 77478
Clinical Research Site
Tampa, Florida, 33614
Clinical Research Site
Tampa, Florida, 33634
Clinical Research Site
Tempe, Arizona, 85282
Clinical Research Site
Toms River, New Jersey, 08755
Clinical Research Site
Troy, Michigan, 48085
Clinical Research Site
Tucson, Arizona, 85710
Clinical Research Site
Walnut Creek, California, 94596
Clinical Research Site
West Covina, California, 91790
Clinical Research Site
Wichita, Kansas, 67214
Clinical Research Site
Woodmere, New York, 11598

Other trials in United States

Puerto Rico2 sites

Clinical Research Site
Bayamón, Puerto Rico, 00961
Clinical Research Site
San Juan, Puerto Rico, 00918

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About this study

Official 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

Read the detailed description

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

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
Being tested: AXS-05, Placebo
Keywords: AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ADVANCE-2
Medical subject headings: Alzheimer Disease, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AXS-05Drug
AXS-05 tablets, taken twice daily
PlaceboDrug
Placebo tablets, taken twice daily

Study groups in NCT05557409
Study group	Role	What they receive
AXS-05	Experimental	Up to 5 weeks Receives: Drug: AXS-05
Placebo	Placebo comparator	Up to 5 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohen-Mansfield Agitation Inventory (CMAI)
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).
Measured: Up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 202221 Dec 2024

First posted28 Sep 2022
Study start6 Sep 2022
Primary completion21 Nov 2024
Study completion21 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Agitation in Patients With Dementia of the Alzheimer's TypeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05557409
Sponsor's protocol ID: AXS-05-AD-304
Acronym: ADVANCE-2
Status last verified: Jul 2026
First submitted: 23 Sep 2022
Last updated: 13 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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