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Study identifier: NCT03082755 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Alzheimer Disease  ·  Sponsor: University of Texas at Austin

PhasePhase 4
Planned participants156
Who can joinAll sexes, 55 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Kathy Richards, PhD  ·  7039463725  ·  kricha@autexas.edu

Always discuss trial participation with your own doctor first.

Locations (1)

The University of Texas at AustinAustin, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03082755