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

NCT05557409

CompletedPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation

Interventions: AXS-05, Placebo

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 65 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (55)
  • Peoria, Arizona, United States
  • Tempe, Arizona, United States
  • Tucson, Arizona, United States
  • Canoga Park, California, United States
  • Long Beach, California, United States
  • Los Alamitos, California, United States
  • Walnut Creek, California, United States
  • West Covina, California, United States
  • Bonita Springs, Florida, United States
  • Brandon, Florida, United States
  • Green Acres, Florida, United States
  • Hialeah, Florida, United States
  • Hollywood, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Gardens, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Augusta, Georgia, United States
  • College Park, Georgia, United States
  • Columbus, Georgia, United States
  • + 25 more on CT.gov