By Kathleen Berger, Executive Producer for Science and Technology

Many Alzheimer’s patients develop agitation, which can be extremely distressing. Inaugural Henry & Amelia Nasrallah Endowed Professor and Director of Geriatric Psychiatry at Saint Louis University George T. Grossberg, M.D., has vast experience providing support for Alzheimer’s patients and family members.

“One of the most common and most disabling symptoms in Alzheimer’s disease is agitation. It’s very impactful and very difficult on patients and particularly difficult for families and care partners to manage,” said Grossberg.

Grossberg said agitation is one of the leading reasons why Alzheimer’s patients end up in nursing homes or facilities for memory care patients.

“When the loving and dedicated family finally just throws the towel in and says ‘I just can’t do this anymore’ because their loved one is agitated, maybe overtly aggressive, maybe even striking out or maybe is yelling and screaming and cursing all the time. Or, pacing incessantly, they can’t be redirected. That’s what the spectrum of agitated behaviors is all about,” he said.

Traditionally, doctors might prescribe antipsychotic drugs that are “off-label” to treat symptoms like aggression and agitation, but Grossberg said that can be problematic.

“With tranquilizing medications that basically don’t have any good evidence that they work, except they sedate or tranquilize the individual, and serious side effects,” Grossberg explained. “Increase risk of falls, making cognitive impairment worse. In some individuals, they could have parkinsonian-like side effects.”

So, Grossberg and his collegues were instrumental in developing the first and only Food and Drug Administration (FDA) approved treatment for agitation associated with Alzheimer’s dementia.  In a paper published in JAMA Neurology, they shared the results of a national clinical trial. They discovered that REXULTI, also called brexpiprazole, significantly reduced agitation in patients with Alzheimer’s disease and was well tolerated with few side effects.

As senior author of the research paper, Grossberg designed studies for the already approved FDA medication that’s meant for something different.They wanted to see if brexpiprazole would work for agitation in Alzheimer’s patients.

“Brexpiprazole, which is currently for augmentation in depression, can be added to an antidepressant,” he explained. “It’s also approved for treatment of psychosis in schizophrenia, usually at higher doses.”

In the multicenter Phase 3 clinical trial, researchers evaluated the efficacy and safety of brexpiprazole for patients with agitation associated with Alzheimer’s. The drug proved both safe and effective. For the majority of patients, it noticeably reduced agitation. RUXULTI is now FDA approved to treat agitation associated with  Alzheimer’s dementia.

“Between 60 (percent) and 70-75% of patients have a good response to the medication,” said Grossberg. “For any drug in this space, and in general, to be approved, the clinician and the family have to notice a clinical improvement.”