Summary:
The ADVANCE Study is recruiting seniors 65 to 90 years of age who have been diagnosed with Alzheimer’s disease and are experiencing agitation symptoms to take part in a clinical research study. The purpose of the study is to determine the safety and effectiveness of an investigational medication for agitation in patients with Alzheimer’s disease.
Qualified Participants Must:
• Be 65 to 90 years of age
• Have a diagnosis of probable Alzheimers disease
• Have a caregiver who is willing and able to comply with the study instructions
• Have symptoms of agitation/aggression. e.g. throwing things, hitting, yelling, pacing, repeating questions, inappropriate undressing, sneaking out
Qualified Participants May Receive:
Individuals will be evaluated to determine their eligibility to participate in the study. If eligible, study participants will receive the study drug (AXS-05), an active control (bupropion), or a placebo control (inactive substance) orally as a tablet taken twice daily for five consecutive weeks. All three products look identical, but only AXS-05 contains the active drug intended to treat your loved one’s agitation. Study participants will also receive study-related medical exams and laboratory tests at no cost. Compensation for time and travel may also be available.