RecruitingPhase 4NCT03082755

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


Sponsor

University of Texas at Austin

Enrollment

156 participants

Start Date

Jul 1, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a medication called gabapentin enacarbil (GEn) to treat nighttime agitation and restless legs syndrome (an uncontrollable urge to move the legs at rest) in people living with Alzheimer's disease, since these nighttime symptoms can severely disrupt sleep and caregiver wellbeing. **You may be eligible if...** - You are 55 or older with a doctor's diagnosis of Alzheimer's-type dementia - You have nighttime agitation (significant restlessness and disruptive behavior at night) - You have been assessed and found to have restless legs syndrome by the study team - You are medically stable and your medications have not changed in the past 14 days - You are able to swallow medications and walk (with or without assistance) - You live with a caregiver (family member or hired help) who lives with you full-time **You may NOT be eligible if...** - You are already being treated for restless legs syndrome with gabapentin or the study drug - You have Parkinson's disease or another disorder causing tremor - You consume alcohol regularly (as it can increase sedation with this medication) - You have severe kidney impairment or are on dialysis - You are taking high-dose opioid pain medications - You have severe psychosis - You live independently in the community without a live-in caregiver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGabapentin Enacarbil

1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks.

DRUGPlacebo Oral Tablet

1 to 2 Placebo Oral Tablets will be administered once a day in the evening (about 5pm) for 8 weeks.


Locations(1)

The University of Texas at Austin

Austin, Texas, United States

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NCT03082755


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