Alzheimer's agitation drug safety trial ends early

NCT ID NCT06736509

Terminated Disease control Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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

Summary

This study tested the long-term safety of AXS-05, a combination of dextromethorphan and bupropion, for treating agitation in people with Alzheimer's disease. It enrolled 139 participants who had completed earlier studies. The trial was terminated early, so the full safety picture is incomplete.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: AXS-05 (dextromethorphan and bupropion combination tablet)
What this could lead to: If successful, this could provide a long-term treatment option to safely manage agitation in people with Alzheimer's disease.
What could go wrong: The study was terminated early, so results are limited. It was an open-label extension, meaning no placebo group, which can make safety findings less reliable.

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

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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, 85381, 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

Greenacres City, Florida, 33467, United States
Clinical Research Site

Hialeah, Florida, 33012, United States
Clinical Research Site

Miami, Florida, 33126, 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 Gardens, Florida, 33014, United States
Clinical Research Site

Miami Lakes, Florida, 33014, 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

Braintree, Massachusetts, 02184, United States
Clinical Research Site

Brooklyn, New York, 11229, United States
Clinical Research Site

Charlotte, North Carolina, 28211, United States
Clinical Research Site

Mesquite, Texas, 75149, United States
Clinical Research Site

Arlington, Virginia, 22205, United States
Clinical Research Site

San Juan, 00918, Puerto Rico

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