June 14, 2023
The Food and Drug Administration recently approved the first drug specifically to treat agitation in people with Alzheimer’s disease. The drug, Rexulti, is given once a day as an oral tablet.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” said Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Agitation can include symptoms ranging from pacing or restlessness to verbal and physical aggression.”
Agitation and aggression are extremely common problems in men and women in the more advanced stages of Alzheimer’s disease. As many as three out of four of those with Alzheimer’s disease will exhibit such symptoms as the disease progresses.
The emotional distress, physical and verbal aggression, irritability, and disruptive and unpredictable outbursts typical of agitation pose dangers for patients and caregivers alike. These behaviors also increase stress for those affected and those who care for them, and can lead to depression in caregivers. Agitation and aggression fall into the category of behaviors called disruptive behaviors and are common reasons why those with Alzheimer’s can no longer live at home and must be placed in a nursing home or assisted-living facility.
The approval was based on two studies that looked at the effects of Rexulti in people with Alzheimer’s disease and symptoms of agitation. Participants ranged in age from 51 to 90. Over a 12-week period, Rexulti was more effective in easing the behavioral symptoms of agitation compared to a placebo drug.
The drug had previously been approved to treat serious depression and schizophrenia, so doctors could prescribe it “off label” to adults with dementia. The expanded FDA approval could make it more widely available for those with Alzheimer’s disease.
The drug, which goes by the scientific name brexpiprazole, is started at a low dosage of half a milligram a day, then is gradually increased to 2 to 3 milligrams a day. The most common side effects included weight gain, sleepiness, dizziness, symptoms of the common cold, and restlessness or feeling that you had to move.
But in rare instances, Rexulti can cause more serious side effects, including an increased risk of dying early. The drug will retain a so-called Boxed Warning indicating that it can raise the risk of death in elderly people who have dementia-related psychosis, a difficulty distinguishing between what is real or not due to confusion and memory loss. The warning adds that the drug is not approved for the treatment of people with dementia-related psychosis who do not have agitation.
Because of these concerns, experts caution that powerful psychiatric drugs like Rexulti not be overused in people with Alzheimer’s disease. Other studies have shown that alternative non-drug therapies like massage, touch therapy, exercise and music therapy — often used in combination —can be an effective way to reduce aggression and agitation in people with Alzheimer’s disease. These non-drug treatments are far safer than medications and, in many cases, should be given priority in treating disruptive behaviors in people with dementia, some experts say.
Doctors say that benefits and risks of various therapies must be carefully weighed when treating agitation in people with Alzheimer’s. Sometimes drugs are the right choice for easing the agitation of dementia, especially in the case of an acute crisis. Non-drug treatments may in some cases also be appropriate as a complement to drug therapies, for example for longer-term treatment or perhaps as a prevention mechanism, allowing lower, and safer, doses of medications to be used.
Reducing noise and distractions in the home may also provide some relief. Regular medical and dental care is also essential to rule out pain and other health problems that may be increasing agitation.
By ALZinfo.org, The Alzheimer’s Information Site. Reviewed by Eric Schmidt, Ph.D., Fisher Center for Alzheimer’s Research Foundation at The Rockefeller University.
Source: Food and Drug Administration, Rexulti.com