By Ashley M. Casey
Associate Editor
The novel coronavirus has infected more than 500,000 people in New York State, but nearly as many New Yorkers — 400,000 people — are battling another epidemic: Alzheimer’s disease.
“When we face pandemics like COVID, those are really up front and in front of our eyes. Alzheimer’s is another pandemic that has been affecting thousands of people for many years,” said Lisa Sonneborn, founder and site director of Clarity Clinical Research in East Syracuse.
To help combat this degenerative brain disease, which is the most common form of dementia, Clarity Clinical Research is seeking volunteers for the “Green Memory” study, which will explore the possibility that rebalancing bacteria in the digestive system could slow the progression of Alzheimer’s. The study will use GV-971, a drug derived from algae.
“Last year in China, one of the first drugs globally was approved for the treatment of mild to moderate Alzheimer’s,” Sonneborn said. “What was really exciting about the Green Memory study is this study is taking a very different approach to studying Alzheimer’s and how to treat it. It feels like we’ve been hitting our head against the wall for years.”
According to Science magazine, Chinese researchers reported “solid and consistent cognition improvement” among people given the drug in a double-blind study of 818 participants.
“If we can rebalance or modulate that bacteria, we can potentially reduce inflammation in the brain and possibly restore memory function,” Sonneborn said.
Clarity Clinical Research, which specializes in studying diseases of memory loss, is one of about 80 research centers across North America participating in the Green Memory study. Researchers are seeking at least 2,000 volunteers, especially those of African American or Hispanic descent.
“African Americans are about twice as likely as whites to develop Alzheimer’s disease, and Hispanics are about one-and-one-half times as likely. However, these high-risk populations are underrepresented in clinical studies,” reads a press release from Clarity Clinical Research about the study.
To qualify for the study, participants must be between the ages of 50 and 85, have a diagnosis of mild to moderate Alzheimer’s disease, and have a study partner who knows them well, sees them at least three times a week and can accompany them to appointments related to the study. There is no cost to participants.
Participants will attend seven appointments at Clarity Clinical Research over the course of a year, and four additional appointments will be conducted over the phone. Half of the patients will receive the GV-971 drug and half will receive a placebo.
After the initial one-year study period, participants may be able to receive the actual medication for 26 weeks.
Sonneborn said Clarity Clinical Research registered the first Green Memory study participant Oct. 27.
“We jump-started the world on this,” she said.
The COVID-19 pandemic has led to changes in how clinical trials are being conducted, Sonneborn said. Researchers are allowing for more flexible appointment times, conducting telehealth visits and even administering procedures at a patient’s home.
“Across the board in pretty much all of our clinical trials there have been additional steps taken to protect participants,” Sonneborn said. “I really do think this is going to be a way that changes how we conduct trials in the future, not just because of COVID. We can collect this data well and provide a positive patient experience.”
Sonneborn, who was named Healthcare Innovator of 2019 by the Central New York Business Journal, said it has been rewarding “to be able to see the response of our patients, who are so excited to get involved in the research.”
“It really is special work that we get to do with our community,” she said.
To learn more about the Green Memory study and other clinical trials, visit clarityclinicalresearch.com or call 315-760-5905.
