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

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.

Timeline

Start

2017-07-01

Primary completion

2022-08-31

Completion

2023-03-31

Publications

• Richards K, Morrison J, Wang YY, Rangel A, Loera A, Hanlon A, Lozano A, Kovach C, Gooneratne N, Fry L, Allen R. Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest). Res Gerontol Nurs. 2020 Nov 1;13(6):280-288. doi: 10.3928/19404921-20200918-01. Epub 2020 Sep 24.

Drugs

Indications