Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
University of Texas at Austin
Summary
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.
Description
Nighttime agitation and sleep disturbance in persons with dementia (PWD) causes patient suffering, may accelerate cognitive decline, leads to burdened caregivers, and is costly to manage. Pharmacological interventions are primarily antipsychotics and hypnotics. Effectiveness is unconvincing, and these drugs are associated with falls, strokes, and death. There is a lack of tailored, effective, and sustainable treatments for nighttime agitation and sleep disturbance in PWD. The investigators approach to this problem is innovative because, unlike pharmacological interventions in the past, it tail…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugGabapentin Enacarbil
1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks.
- DrugPlacebo Oral Tablet
1 to 2 Placebo Oral Tablets will be administered once a day in the evening (about 5pm) for 8 weeks.
Location
- The University of Texas at AustinAustin, Texas