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

Recruiting in Palo Alto (17 mi)

Overseen byKathy Richards, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Texas at Austin

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

Inclusion Criteria

Aged >=55 years

Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia

Physician diagnosis of dementia of the Alzheimer's type

+7 more

Exclusion Criteria

You are currently taking gabapentin.

You have Parkinson's disease or any other condition that causes tremors as this may make it difficult to accurately diagnose and monitor your condition.

You have a serious mental illness called psychosis that affects your ability to think and behave normally.

+10 more

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Gabapentin Enacarbil (GEn)Experimental Treatment1 Intervention

1 to 2 GEn tablets (300 mg) will be administered by mouth (PO) once a day in the evening (about 5 pm) for 8 weeks then tapered for 1 week. The study drug will be adjusted up to a maximum dosage of 600 mg as tolerated.

Group II: PlaceboPlacebo Group1 Intervention

1 to 2 Placebo Oral Tablet(s) will be administered once a day in the evening (about 5 pm) for 8 weeks then tapered for 1 week. The placebo drug will be adjusted up to a maximum dosage of 2 tablets as tolerated.