Start: July 2017
End: March 31, 2023
What Is This Study About?
Restless legs syndrome (RLS) may contribute to nighttime agitation in people with Alzheimer's disease. In this study, researchers will explore whether an approved treatment for RLS, gabapentin enacarbil, can improve sleep in nursing home residents with Alzheimer's and nighttime agitation. Participants will take one to two tablets of either the study drug or a placebo by mouth once daily for eight weeks. Wristwatch-sized tracking devices will be used to help track sleep data.
Do I Qualify To Participate in This Study?
- Diagnosis of Alzheimer's disease
- Clinical Dementia Rating score of 0.5 to 3, indicating moderate to severe dementia
- Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score >=35
- 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)
Must NOT have:
- Received 50 mg or more per day of morphine in the last 14 days
- Currently being treated with gabapentin or GEn
- 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
- Living independently in the community without a live-in caregiver, whether family or hired
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Kathy Richards, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: University of Texas at Austin
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03082755