The drug, called AVP923, has approval from the Food and Drug Administration (FDA) to treat a disorder called pseudobulbar affect. The study, led by Cleveland Clinic neurologist Jeffrey L. Cummings, MD, suggests that the drug also may help manage agitation in patients with Alzheimer’s.
People with Alzheimer’s experience a number of symptoms that are disabling. As the disease progresses, more severe symptoms emerge. One of the most debilitating is agitation. This condition can cause people with Alzheimer’s to lash out physically and verbally at others, or become restless or upset.
No drugs available
While there are strategies to lessen the environmental stimulation that can prompt or exacerbate agitation in people with Alzheimer’s, no drugs are available to treat this common condition.
Researchers led by Dr. Cummings in the randomized, double-blind trial studied a total of 220 patients with Alzheimer’s disease between the ages of 50 and 90. They found that people with moderate to severe agitation who took the drug saw a 60 percent reduction in symptoms compared to the control group.
Reduction of the symptoms began within a week of starting the medicine. The decreased symptoms lasted through the study’s entire 10 weeks.
“The results of the trial for the drug AVP923 showed that patients who received it had a statistically significant reduction in their agitation compared to those who received a placebo,” says Dr. Cummings. Dr. Cummings is Director of Cleveland Clinic’s Lou Ruvo Center for Brain Health in Las Vegas and Cleveland.
Different symptoms, different stages
Agitation is a direct result of Alzheimer’s disease. It may be caused by a number of factors, including medication or a biological inability to deal with new information or stimulation.
Agitation often causes someone to shout, kick, curse, and throw things. It often makes it difficult for caregivers to provide care. Agitation is one of the main reasons people with Alzheimer’s move to nursing homes for care.
“If we’re able to treat agitation effectively, we’ll be able to keep patients home for a longer period of time,” Dr. Cummings says. “That will be a great win for patients and their families.”
The drug still needs to undergo one more type of study before the FDA will consider approving it to treat Alzheimer’s agitation, Dr. Cummings says. That process probably will take two to three years.
Numbers to grow
Other debilitating symptoms of the disease include:
- Mood conditions including depression, irritability and anxiety
- Memory loss
More than 5 million Americans have Alzheimer’s disease. The disease costs the nation $200 billion in direct health care costs.
As the percentage of Americans older than 65 continues to grow, estimates are that the number of people with Alzheimer’s will nearly triple to 13.8 million in 2050, with health care costs ballooning to $1.2 trillion.