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FDA Approves First Drug to Treat Agitation Symptoms in Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) has approved Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer's disease. This is the first FDA-approved treatment option for this indication.


Agitation is a common and challenging symptom of Alzheimer's disease. It can manifest in a variety of ways, including restlessness, irritability, aggression, and verbal outbursts. Agitation can be disruptive to both the person with Alzheimer's disease and their caregivers.


Rexulti is a newer antipsychotic medication that has been shown to be effective in reducing agitation in people with Alzheimer's disease. In two clinical trials, Rexulti was shown to be significantly more effective than placebo in reducing agitation symptoms.


The most common side effects of Rexulti include restlessness, sleep problems, and weight gain. Rexulti should not be used in people with a history of psychosis or suicidal thoughts.


The approval of Rexulti is a significant development for people with Alzheimer's disease and their caregivers. It provides a new treatment option for a common and challenging symptom of the disease.


What is agitation?

Agitation is a common symptom of Alzheimer's disease. It can be defined as a state of restlessness, irritability, or anxiety. Agitation can manifest in a variety of ways, including:


Restlessness

Irritability

Aggression

Verbal outbursts

Wandering

Sleep disturbances

Agitation can be disruptive to both the person with Alzheimer's disease and their caregivers. It can make it difficult for the person with Alzheimer's disease to participate in activities of daily living, and it can lead to stress and anxiety for the caregiver.


What causes agitation?

The exact cause of agitation in Alzheimer's disease is unknown. However, it is thought to be caused by a combination of factors, including:


The progression of the disease itself

Changes in brain chemistry

Medication side effects

Environmental stressors

How is agitation treated?

There is no cure for agitation in Alzheimer's disease. However, there are a number of treatments that can help to reduce the symptoms. These treatments include:


Non-pharmacologic treatments: These treatments include behavioral interventions, such as positive reinforcement and environmental modification.

Pharmacologic treatments: These treatments include medications, such as antipsychotics, antidepressants, and mood stabilizers.

What are the risks of treatment?

All treatments for agitation have risks. Non-pharmacologic treatments can be time-consuming and difficult to implement. Pharmacologic treatments can have side effects, such as drowsiness, restlessness, and weight gain.


What is the outlook for people with agitation?

The outlook for people with agitation is variable. Some people experience a significant improvement in their symptoms with treatment. Others continue to experience symptoms despite treatment.


What can I do to help?

If you are caring for someone with agitation, there are a number of things you can do to help:

Be patient and understanding. Agitation is a common and difficult symptom of Alzheimer's disease.

Create a calm and structured environment. This can help to reduce stress and anxiety, which can trigger agitation.

Provide positive reinforcement. Reward the person with positive attention when they are calm and cooperative.

Avoid arguing or getting into power struggles. This can only make the agitation worse.

Seek professional help. If you are struggling to manage the agitation, talk to your doctor or a caregiver support group.

The approval of Rexulti is a significant development for people with Alzheimer's disease and their caregivers. It provides a new treatment option for a common and challenging symptom of the disease.

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