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Hope for Alzheimer's agitation: new drug shows promise in major trial

NCT ID NCT05557409

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study tested an experimental drug called AXS-05 to see if it can safely reduce agitation in people with Alzheimer's disease. About 408 participants took either the drug or a placebo for several weeks. The goal was to measure changes in agitation using a standard rating scale.

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

408 people

The number who actually took part.

Started

Sep 2022

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: * 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.

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

Contacts and locations

Locations

  • Clinical Research Site

    Peoria, Arizona, 85381, United States

  • Clinical Research Site

    Tempe, Arizona, 85282, United States

  • Clinical Research Site

    Tucson, Arizona, 85710, United States

  • Clinical Research Site

    Canoga Park, California, 91303, United States

  • Clinical Research Site

    Long Beach, California, 90807, United States

  • Clinical Research Site

    Los Alamitos, California, 90720, United States

  • Clinical Research Site

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    West Covina, California, 91790, United States

  • Clinical Research Site

    Bonita Springs, Florida, 34134, United States

  • Clinical Research Site

    Brandon, Florida, 33511, United States

  • Clinical Research Site

    Green Acres, 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

    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

    Augusta, Georgia, 30912, United States

  • Clinical Research Site

    College Park, Georgia, 30349, United States

  • Clinical Research Site

    Columbus, Georgia, 31909, United States

  • Clinical Research Site

    Wichita, Kansas, 67214, United States

  • Clinical Research Site

    Marrero, Louisiana, 70072, 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

    Troy, Michigan, 48085, United States

  • Clinical Research Site

    Chesterfield, Missouri, 63005, United States

  • Clinical Research Site

    Berlin, New Jersey, 08009, 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

    Woodmere, New York, 11598, United States

  • Clinical Research Site

    Charlotte, North Carolina, 28211, United States

  • Clinical Research Site

    Hickory, North Carolina, 28601, United States

  • Clinical Research Site

    Middleburg Heights, Ohio, 44130, 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

    San Antonio, Texas, 78229, United States

  • Clinical Research Site

    Sugarland, Texas, 77478, United States

  • Clinical Research Site

    Rutland, Vermont, 05701, United States

  • Clinical Research Site

    Arlington, Virginia, 22205, United States

  • Clinical Research Site

    Bayamón, Puerto Rico, 00961, Puerto Rico

  • Clinical Research Site

    San Juan, Puerto Rico, 00918, Puerto Rico

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