Study Type

Healthy Aging & Alzheimer's Disease

Study Purpose

The ADVANCE research study will evaluate the effectiveness and safety of a study drug called AXS – 05 in patients that experience agitation with Alzheimer’s disease.

People with Alzheimer’s disease may experience agitation, a common symptom where patients endure irritability, aggression and/or anxiousness.

About the Study

Participants will visit the Pennington Biomedical Outpatient Clinic for a screening visit to determine if you are eligible for the study. Once enrolled, participants will be randomly assigned to either the study drug group or the placebo (non-drug) group and will participate in the study for roughly 7 weeks.

Study Design

Number of Visits: 

  • 1 screening visit
  • 5 study visits
  • 1 follow up phone call


  • Physical exam (height and weight)
  • Vital signs (blood pressure and pulse)
  • Medical history
  • Questionnaires
  • Medication review
  • Blood tests
  • Urine tests
  • Electrocardiogram (ECG)

Study Qualifications

To qualify for this research study, participants should:


  • Be between 65 to 90 years old
  • Have a diagnosis of probable Alzheimer’s disease
  • Have a caregiver willing to attend study visits

* You may not qualify for this study based on other eligibility criteria not listed. The study coordinator will go over this information in detail.

Study Duration

Participation in this research study will last approximately 10 weeks.


Compensation is available for time and travel.

Study Contact

If you and your loved one are interested in participating in this research study, call 225-763-2973 or email


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