Clinical Trial

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated May 18, 2022 (before its estimated August 31, 2022 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2017-03-10; most recent amendment 2024-08-27.
Status change: Recruiting → Completed 2024-08-27
Status change: Not Yet Recruiting → Recruiting 2017-07-18
Trial Details
NCT Number NCT03082755
Lead Sponsor University of Texas at Austin
Collaborators: National Institute on Aging (NIA)
Conditions Alzheimer Disease
Enrollment 156 participants
Start Date 2017-07-01
Primary Completion 2022-08-31 (estimated)
Study Completion 2023-03-31 (estimated)
Updated on ClinicalTrials.gov 2022-05-18