Researchers at The University of Texas at Austin and the University of Wisconsin–Milwaukee have received a $3.9 million, five-year award from the National Institute on Aging to improve treatment of nighttime agitation in persons with Alzheimer’s disease, which commonly occurs and is often devastating. The grant is the largest ever awarded to the UT Austin School of Nursing.
Nighttime agitation or “sundowning” is the appearance or exacerbation of behavioral disturbances, such as wandering and aggression, occurring in the afternoon or evening in persons with Alzheimer’s disease. Nighttime agitation increases the burden and costs of caring for persons with the disease and often results in more restrictive living environments for them.
Kathy Richards, a research professor at the UT Austin School of Nursing, is co-principal investigator of the Nighttime Agitation and Restless Legs Syndrome in the People with Alzheimer’s Disease research project. Christine Kovach, a research professor in aging at the Jewish Home and Care Center at the University of Wisconsin–Milwaukee, is also a co-investigator.
“Safe, effective treatments for nighttime agitation are lacking. One major cause for these past failures has been the ‘one size fits all’ approach,” Richards said. “The precision medicine method we are using tailors treatment to a specific sleep disorder, restless legs syndrome or RLS, that causes discomfort and an inability to sit or lie still in the evening and night. We hypothesize that RLS may be a cause for nighttime agitation and sleep disturbance in people with Alzheimer’s disease.”
Nighttime agitation behaviors are often treated with powerful antipsychotic drugs, but alarming statistics on the prevalence of these medications and their danger to the health of persons with Alzheimer’s disease has resulted in a federal mandate to reduce their use and frequency. This research may lead to a reduction in dangerous antipsychotic medications.
This is the first time that a new diagnostic tool, the Behavioral Indicators Test–Restless Legs, that Richards and her team developed and validated for diagnosing RLS in persons with Alzheimer’s will be used in research on nighttime agitation.
The eight-week, double-blind, randomized controlled trial will include 136 long-term care residents with nighttime agitation and RLS living in long-term care settings in Central Texas. Residents will receive either gabapentin enacarbil (HORIZANT®) the FDA-approved drug for RLS, or a placebo.
“Nighttime agitation is the No. 1 reason why people with Alzheimer’s cannot be cared for at home,” Richards said. “If we can find a better and more precise way to treat nighttime agitation, we can improve the quality of life for many persons who are living with Alzheimer’s disease.”