What is Alzheimer’s-Related Anxiety & Restlessness?
New drug trial tests medication that could provide relief
Charter Research’s clinic trial center in Orlando is seeking candidates for a drug trial aimed at one of the most common and vexing symptoms for Alzheimer’s patients and their caregivers: anxiety, restlessness, and similar symptoms. New medications hold promise for providing relief for these issues (also sometimes called “agitation” or “sundowning“), which appears in 40%-60% of Alzheimer patients and in 75% of moderate to severe dementia sufferers.
What is agitation in Alzheimer’s?
Alzheimer’s-related anxiety and restlessness in all its forms—from finger tapping, nail biting and restlessness to excessive motor activity, verbal aggression, and physical aggression—is particularly challenging because there are currently no effective treatments for it, said Dr. Edgardo Rivera, Charter’s medical director in Orlando.
“It may be very difficult to deal with some of these patients,” he said. “They encounter problems with daily living earlier than patients who are not agitated. These patients tend to be moved to nursing homes earlier.”
This can have an added emotional toll on both the patient and caregiver. “Making the decision to move the patient into a care facility takes an increased toll on the patient, but also on the caregiver because they may want to continue caring for their loved one,” Rivera said. “But they don’t have the physical stamina, the knowledge, or the tools to do that.”
In addition, myriad conditions associated with the Alzheimer’s may cause anxiety and agitation—from sleep disorders to depression to delusions. Doctors and caregivers often turn to non-pharmacological maneuvering or distractions to get patients out of their agitated states.
Current Treatments
When drug treatments are used to control the issues, doctors prescribe medication to treat the underlying cause of the anxiety and agitation—if it is known. For example, sedatives can help address sleeping disorders, Rivera said. However, Alzheimer patients often cannot articulate a cause for their apprehension or restlessness. Neuroleptics, a class of drugs used to treat and manage symptoms associated with various psychiatric disorders, can be prescribed, but there are disadvantages to those as well.
“Those medications may work on some people, but may increase mortality in others,” Rivera said. “You may have to decide whether the increased mortality is a risk that you want to take versus the benefit that the medicine may give you from a quality-of-life perspective. So, it is a difficult conundrum.”
This is why new clinical trials should be of interest to anyone affected by Alzheimer’s. An effective anxiety and agitation treatment could shift the caregiver paradigm immensely.
“If we had something that would be effective and be able to care for patients without the added stress of having to deal with an agitated person, it would be much, much better for the caregivers.”
The Trial Process
The trials at Charter’s clinical research centers in Orlando and The Villages aim to establish the efficacy, safety, and tolerability of the study drug in Alzheimer’s patients with agitation.
A screening period to assess patient eligibility includes diagnostic and physical examinations. Patients whose agitation is attributable to medications, substance abuse, or active medical or psychiatric conditions in the investigator’s judgement will not be eligible to participate.
The double-blinded and placebo-controlled trials means doctors and patients won’t know if the group they are assigned to is receiving the medication or a placebo. Participants take a daily oral medication or placebo.
Caregiver Candor
Rivera adds one of the key characteristics of the screening process will involve assessing the candor of a patient’s caregiver and getting them to relate objectively what they observe.
“We depend on caregivers to provide the information we’re looking for,” he said. “We need them to be extra vigilant in this.”
But it is common for caregivers to try to explain or downplay patient behavior, Rivera said. “They will say something like, ‘Well, he’s like that today because he ate something yesterday that didn’t agree with him.’”
This misguided mindset, even if well intentioned, could lead to potentially significant changes in patient behavior being missed, overlooked, or explained away.
“The person who is taking care of them on a regular basis will know exactly the symptoms we’re looking for, and we rely on them to provide that information to us,” he said. “So, we need an honest assessment from the caregiver. We don’t want them to be under or over reporting, just provide the raw information, and we will process that information accordingly.”
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