Alzheimer’s drug to get trial; Las Vegas volunteers sought

Patsy Quinn knows what the agitation that so often accompanies Alzheimer’s disease can mean.

Having cared for Virgil “Gene” Quinn for more than three years as the disorder ate away at his brain, she knows it can mean the love of your life will often push you away and tell you to “shut up and get the hell out of here” as you try to clean him and give him medication.

Or it can mean his being so agitated when you enter their bedroom one night to check on his condition, he starts to hit you, thinking a stranger has broken into their home.

Given that experience –– her 82-year-old husband died last November in the Solari Hospice –– it should come as no surprise that Quinn hopes a new national drug trial that includes the Cleveland Clinic Lou Ruvo Center for Brain Health, which needs volunteers from Las Vegas, is successful.

The medication, AVP-923, already approved three years ago for the treatment of involuntary, sudden and frequent episodes of laughing and/or crying, would give physicians an FDA approved treatment tool to mitigate behavior that medical experts now believe is often responsible for Alzheimer’s patients having to be placed in expensive facilities.

Without research advances, the Alzheimer’s Association says the costs of care –– there are currently 5.4 million people with the disease in the United States –– are projected to rise from $200 billion today to $1.1 trillion in 2050.

“There is absolutely a need for a new medication,” Quinn said. “You just get beaten down so much as a caregiver. You know this is not the person you love. They’re not behaving like they do because they want to. The disease takes over.”

Currently, the role of the at-home caregiver for Alzheimer’s patients is so stressful that it is not unusual for the caregiver to die before the patient, said Albert Chavez, of the Desert Southwest Chapter of the Alzheimer’s Association.

Dr. Kate Zhong, senior director of clinical research and development at the Ruvo Center and the woman directing the drug trial at the four Cleveland Clinic sites –– in addition to the Nevada center, there are two in Ohio, and one in Florida –– noted that physicians currently must use dangerous anti-psychotic medications and/or addictive sedatives that can further compromise cognition to deal with Alzheimer behavioral issues. There is no FDA drug approved for treating agitation in Alzheimer’s patients.

Anti-psychotic drugs, such as those used for schizophrenia, have shown some short-term benefit, Zhong said, but the increased risk of stroke and death makes their long-term use, particularly on the elderly, controversial.

Benzodiazepines, or sedatives, can be highly addictive –– withdrawal can be agonizing and life-threatening in the older population –– and greatly reduce an individual’s level of consciousness, which is extremely problematic when treating people with cognition deficiency.

Results of earlier research on AVP-923 suggest the drug may be effective in treating agitation associated with dementia, Zhong said.

“And what we already know in terms of dealing with uncontrollable, in­voluntary crying and laughing is that it is safe and well tolerated with the elderly population,” she said.

About 200 individuals will test the drug at sites across the country, with 40 of them participating at Cleveland Clinic centers.

The 10 participants in Las Vegas must have a diagnosis of probable Alzheimer’s disease and must have agitation secondary to the disease.

This can take a verbal form, such as screaming and swearing; a physical dimension, such as destroying objects, grabbing or fighting; or it could be nonaggressive agitation such as continual pacing.

There will be a total of eight clinical visits in this Phase II, double-blind, placebo-controlled eight-week study.

The participant must have a caregiver who is able to attend study visits with them.

“There is no lumbar puncture, spinal tap or imaging –– just a relatively straightforward clinical trial,” Zhong said.

Participants will take an oral medication twice daily for 10 weeks. The local part of the trial will begin after the 10 patients are selected.

Researchers will conduct various cognitive and clinical assessments throughout the study to assess the safety, tolerability and efficacy of AVP-923.

To inquire about the trial, phone 702-685-7073.

Contact reporter Paul Harasim at
pharasim@reviewjournal.com or 702-387-2908.