Actively Recruiting
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
Led by University of Texas at Austin · Updated on 2022-05-18
156
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
U
University of Texas at Austin
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged �3E=55 years
- Clinical Dementia Rating (CDR) score between 0.5 and 3, indicating very mild to severe dementia
- Physician diagnosis of Alzheimer's type dementia
- Nighttime agitation with a Cohen Mansfield Agitation Inventory score of �3E=35
- Physician agrees medication for agitation is appropriate
- Diagnosis of restless legs syndrome by study nurse in consultation with physician
- Medically stable with no medication changes in past 14 days and no acute illness or delirium
- Able to swallow medication
- Ambulatory with or without assistance
- If treated for restless legs syndrome, symptoms must still be present and inclusion confirmed by medical review
You will not qualify if you...
- Taking 50 or more morphine milligram equivalents per day in the past 14 days
- Currently treated for restless legs syndrome with gabapentin or gabapentin enacarbil
- Diagnosis of Parkinson's disease or other tremor-causing disorders
- Receiving gabapentin medication
- Severe psychosis
- Alcohol consumption during the study
- Treatment with gabapentin enacarbil contraindicated by medical team
- Prior failure of gabapentin or gabapentin enacarbil treatment
- Severe kidney impairment or on hemodialysis
- Participating in another clinical trial affecting outcomes
- Assessed at risk for suicide by medical staff
- Any medical condition making participation inappropriate
- Living independently without a live-in caregiver
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas at Austin
Austin, Texas, United States, 78701
Actively Recruiting
Research Team
K
Kathy Richards, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here