Treatment of Restless Legs Syndrome Improves Agitation and Sleep in Persons with Dementia: A Randomized Trial.

Only 143 participants were analyzed for the primary outcome after excluding four people missing blood pressure data. The study was a pilot and did not correct for multiple comparisons, so some secondary findings may be less reliable. Many participants were already taking sedating medications for behavior or sleep, which can make agitation and sleep outcomes harder to interpret. Actigraphy sleep data were missing for many participants, so sleep duration results were based on observed data. The safety monitoring board stopped study drug or placebo in the 6 remaining participants because of falls and sedation. The trial was done during and after the COVID-19 pandemic, and staffing shortages may have affected caregiver ratings and fall reporting. When participants with medication changes during the trial were excluded, some significant findings became nonsignificant. The groups differed at baseline in blood pressure, and analyses had to adjust for this.

The investigators designed the trial, analyzed the data, and wrote the manuscript. Arbor Pharmaceuticals provided the study drug and placebo, and Azurity Pharmaceuticals markets Horizant; the paper says these companies did not influence design, conduct, or publication.

Do not conclude GEn safely treats agitation in dementia. It improved nighttime agitation, not agitation from 5 pm to 10 pm, and falls and sedation were more common.