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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.
Details
| Lead sponsor | University of Texas at Austin |
|---|---|
| Phase | PHASE4 |
| Status | RECRUITING |
| Enrolment | 156 |
| Start date | Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Mar 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Alzheimer Disease
Interventions
- Gabapentin Enacarbil
- Placebo Oral Tablet
Countries
United States