Alzheimer's Disease — Clinical Trials and the Logic of Clinical Purpose

Agitation, aggression, delusions, and hallucinations are among the most common and disabling symptoms of Alzheimer's disease. These problems diminish the quality of life for both the patient and caregiver.1 They are also costly.2 Treatments for these symptoms include the second-generation, or “atypical” antipsychotic medications.The Food and Drug Administration (FDA) labels for antipsychotic medications state bluntly that they are not approved for the treatment of dementia-related psychosis, and they display a “black-box” warning: “Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.”3 Yet, clinicians, including me, continue to prescribe . . .