Studying a drug for Alzheimer’s agitation

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By Margaret Foster
Posted on July 13, 2021

Alzheimer’s disease is devastating to a patient’s family not only because of memory loss but because of changes in a loved one’s behavior. In addition to wandering away from caregivers, patients can become anxious, irritable, agitated or even violent.

Now a study is under way to see if a drug can help alleviate agitation caused by Alzheimer’s. Sponsored by Avanir Pharmaceuticals Inc., the study is a phase-three trial — the last step in being approved by the Federal Drug Administration.

The drug, known as AVP-786, is similar to the FDA-approved drug Nuedexta, and both consist of dextromethorphan and quinidine.

It has been tested in more than a dozen previous studies, and “Results from these studies suggest that AVP-786 is generally well tolerated,” according to Avanir Pharmaceuticals.

Local study site

The phase-three clinical trial, known as the Aspect study, will enroll 750 participants at 110 study centers in the U.S. and Europe, including a site in Richmond: Clinical Research Partners on Forest Ave.

In the double-blind, randomized study, patients will swallow a daily pill of either the study drug or a placebo. They will visit Clinical Research Partners several times to complete assessments and give blood and urine samples. Participants will receive $50 per visit or $500 total for completing the study.

People between 50 and 80 with a probable diagnosis of Alzheimer’s as well as moderate agitation are eligible. They must have caregivers who see them four days a week and can help them complete the study.

“Agitation is found in approximately 50% of individuals with Alzheimer’s dementia,” said Dr. Joseph James, physician at Clinical Research Partners and principal investigator of the study. “Participating in this trial will help scientists to find an effective treatment without significant side effects in the pharmacological management of Alzheimer’s associated agitation.”

For more information, caregivers may call (804) 477-3045 or visit ClinicalResearchRVA.com.