Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
• Aged \>=55 years
• Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia
• Physician diagnosis of dementia of the Alzheimer's type
• Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score \>=35
• Opinion of the participant's physician that medication for agitation is appropriate
• RLS diagnosis by study advanced practice nurse (APN) or registered nurse (RN) (in consult with the participant's physician, and the investigators), using the Behavioral Indicators Test-Restless Legs
• Medically stable, defined as unchanged medications within 14 days and the absence of fever or other signs and symptoms of acute illness or delirium (e.g. urinary tract infection, pneumonia) that may cause agitation or interfere with the study protocol
• Able to swallow medication
• Ambulatory, with and without assistance
• If currently being treated for RLS, may be included if still having RLS symptoms/signs and confirmed as appropriate for inclusion by medical review