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Nighttime Agitation and Restless Legs Syndrome in Nursing Home Residents with Alzheimer's

Recruiting

Nighttime agitation causes distress for people with Alzheimer's and their caregivers. Previous research has identified a possible connection between restless legs syndrome (RLS) and nighttime agitation and sleep disturbance in people with Alzheimer's. In this study, researchers will explore whether RLS may be a cause of nighttime agitation and if an approved treatment for RLS, Horizant (gabapentin enacarbil), reduces or stops agitation and improves sleep. 

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years N/A All No
July 2017
March 31, 2022
136

  • Diagnosis of Alzheimer's disease
  • Clinical Dementia Rating score of 2 or 3, indicating moderate to severe dementia
  • Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score >=40
  • Diagnosis of RLS by study nurse
  • No changes in medications within the past 14 days
  • No fever or other signs of acute illness or delirium
  • Must be able to swallow medication
  • Must be able to walk (assistance devices allowed)

  • Currently taking opioid or antiepileptic drug
  • Currently being treated for RLS
  • Diagnosis of Parkinson's disease or another disorder causing tremor
  • Severe psychosis or at risk for suicide
  • Alcohol consumption
  • Failure of past treatment with similar medications to the study drug
  • Poor renal function, as indicated by creatinine clearance of less than 15 or on hemodialysis
  • Current participation in a clinical trial or study that may affect study outcomes
  • Any condition that makes it medically inappropriate to participate in the trial

The aim of this trial is to better elucidate whether a sleep disorder, restless legs syndrome (RLS), 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. Horizant is a treatment currently approved for RLS. In this late-stage trial, nursing home participants with Alzheimer's disease and nighttime agitation will take 1 to 2 tablets of either the study drug or a placebo by mouth once daily in the evening for 8 weeks. The study drug may be adjusted up to a maximum dosage of 600 mg. Researchers will compare the effect of the study drug versus placebo on RLS behaviors, nighttime agitation, and sleep disturbances. Wristwatch-sized tracking devices will be used to help track sleep data.

Name City State Zip Status Primary Contact
The University of Texas at Austin
Austin Texas 78701 Recruiting Janet D Morrison, PhD
512-965-4023
jmorrison@mail.nur.utexas.edu

University of Texas at Austin

  • National Institute on Aging (NIA)

Name Role Affiliation
Kathy Richards, PhD Principal Investigator University of Texas at Austin
Christine Kovach, PhD Principal Investigator University of Wisconsin, Milwaukee

Name Phone Email
Janet D. Morrison, PhD 512-471-8061 jmorrison@mail.nur.utexas.edu

NCT03082755

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