A recent study found that a drug currently marketed under the trade name Nuedexta, which is approved by the Federal Drug Administration to treat pseudobulbar affect, a neurologic disorder defined by uncontrolled emotional responses, may also reduce agitation in patients with Alzheimer’s disease.
The study, which was published in the Journal of the American Medical Association, compared the effect of Nuedexta to a placebo in 220 Alzheimer’s disease patients with moderate to severe symptoms of agitation. The clinical trial was performed across 42 research sites, including the University of Rochester Medical Center where Anton Porsteinsson, M.D., professor of Psychiatry at the URMC, enrolled patients in the study from across Upstate NY.
Nuedexta is a combination of dextromethorphan hydrobromide, which helps control emotions by acting at several different receptors in the brain, and quinidine sulfate, which inhibits the degradation of dextromethorphan allowing it to reach therapeutic levels in the blood stream and brain.
Though the trials lasted ten weeks, “Drug showed superiority over placebo starting at week one, which is unusually rapid onset of action for any pharmacological intervention for this condition”, says Porsteinsson “Any which way we looked at this group, drug was superior to placebo in terms of reducing agitation.”
This reduction in agitation was apparent not only to researchers conducting the study, but also to clinicians who interviewed the patients and their caregivers without any prior knowledge of patient information gathered by the study. These blinded interviews solidified the claim that Nuedexta provides a meaningful benefit to the patient, but also showed that the drug substantially reduced the burden on the caregivers.
Many caregivers cite loss of emotional control and agitation as the most traumatic aspect of the Alzheimer’s disease. “This is what burdens caregivers the most – these behavioral disruptions. This is what they identify as the most stressful part of caring for someone with Alzheimer’s”, says Porsteinsson.
Up to this point, Alzheimer’s patients have often been prescribed antipsychotic medications to control agitation. Proof that these drugs work is scant and they have severe side effects, including death. That is why Porsteinsson and other researchers teamed up with the study’s lead author, Jeffrey Cummings, M.D., director of the Cleveland Clinic Lou Ruvo Center for Brain Health, to study Nuedexta.
The team hopes to “switch the focus of treatment to a medication that has better evidence base for being both safe and effective”, says Porsteinsson.
Avanir Pharmaceuticals, Inc., which funded the study, is currently moving Nuedexta into the final stages of clinical trials. These trials will seek to replicate the findings of the current study in a larger population and address concerns of increased falls in patients taking Nuedexta, which was the only major side effect found by the current study. Pending the results of the final clinical trials, Nuedexta may soon be available to offer relief to Alzheimer’s patients and their families.