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New hope for Alzheimer's agitation: drug shows promise in large trial

NCT ID NCT04947553

Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety and effectiveness of a drug called AXS-05 for treating agitation in people with Alzheimer's disease. A total of 456 participants who had already been in earlier studies took part. The goal was to see if the drug could safely reduce agitation symptoms and prevent them from coming back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

456 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304. * Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment. Exclusion Criteria: * Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. * Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. * Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. * Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation in patients with dementia of the Alzheimer's type Agitation,psychomotor Alzheimer disease

Contacts and locations

Locations

  • Clinical Research Site

    Peoria, Arizona, 83581, United States

  • Clinical Research Site

    Tempe, Arizona, 85282, United States

  • Clinical Research Site

    Long Beach, California, 90807, United States

  • Clinical Research Site

    Santa Ana, California, 92705, United States

  • Clinical Research Site

    Temecula, California, 92591, United States

  • Clinical Research Site

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    Bonita Springs, Florida, 34134, United States

  • Clinical Research Site

    Brandon, Florida, 33511, United States

  • Clinical Research Site

    Coral Springs, Florida, 33067, United States

  • Clinical Research Site

    Greenacres City, Florida, 33467, United States

  • Clinical Research Site

    Hialeah, Florida, 33012, United States

  • Clinical Research Site

    Hollywood, Florida, 33024, United States

  • Clinical Research Site

    Kissimmee, Florida, 34741, United States

  • Clinical Research Site

    Lake City, Florida, 32055, United States

  • Clinical Research Site

    Miami, Florida, 33126, United States

  • Clinical Research Site

    Miami, Florida, 33135, United States

  • Clinical Research Site

    Miami, Florida, 33145, United States

  • Clinical Research Site

    Miami, Florida, 33155, United States

  • Clinical Research Site

    Miami, Florida, 33165, United States

  • Clinical Research Site

    Miami, Florida, 33173, United States

  • Clinical Research Site

    Miami, Florida, 33175, United States

  • Clinical Research Site

    Miami Gardens, Florida, 33014, United States

  • Clinical Research Site

    Miami Lakes, Florida, 33014, United States

  • Clinical Research Site

    Orlando, Florida, 32807, United States

  • Clinical Research Site

    Pembroke Pines, Florida, 33025, United States

  • Clinical Research Site

    Tampa, Florida, 33614, United States

  • Clinical Research Site

    Tampa, Florida, 33634, United States

  • Clinical Research Site

    Trinity, Florida, 34655, United States

  • Clinical Research Site

    Columbus, Georgia, 31909, United States

  • Clinical Research Site

    Wichita, Kansas, 67214, United States

  • Clinical Research Site

    Braintree, Massachusetts, 02184, United States

  • Clinical Research Site

    Flint, Michigan, 48532, United States

  • Clinical Research Site

    Rochester Hills, Michigan, 48307, United States

  • Clinical Research Site

    Chesterfield, Missouri, 63005, United States

  • Clinical Research Site

    Toms River, New Jersey, 08755, United States

  • Clinical Research Site

    Brooklyn, New York, 11229, United States

  • Clinical Research Site

    New Windsor, New York, 12553, United States

  • Clinical Research Site

    Staten Island, New York, 10314, United States

  • Clinical Research Site

    Charlotte, North Carolina, 28211, United States

  • Clinical Research Site

    Hickory, North Carolina, 28601, United States

  • Clinical Research Site

    Austin, Texas, 78737, United States

  • Clinical Research Site

    Cypress, Texas, 77429, United States

  • Clinical Research Site

    Mesquite, Texas, 75149, United States

  • Clinical Research Site

    Sugar Land, Texas, 77478, United States

  • Clinical Research Site

    Arlington, Virginia, 22205, United States

  • Clinical Research Site

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Clinical Research Site

    San Juan, 00918, Puerto Rico

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