Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
University of Texas at Austin
156 participants
Jul 1, 2017
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks.
1 to 2 Placebo Oral Tablets will be administered once a day in the evening (about 5pm) for 8 weeks.
Locations(1)
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NCT03082755