Newswise — Faculty at the University of North Carolina Wilmington have played a key role in designing, analyzing and interpreting a national clinical trial study of a new drug that may help people with mild cognitive impairment, a condition that is often a precursor to Alzheimer's disease.
Dr. Julian Keith, professor of psychology at UNC Wilmington and director of neuroscience for Memory Assessment Research Services (MARS), LLC, designed the clinical trial protocol for Allon Therapeutics, Inc., the company testing the drug.
Keith, along with fellow UNCW faculty and MARS colleagues, Dr. Len Lecci and Dr. Dale Cohen, was asked by Allon to participate in designing the study. Keith said the team was given the freedom to design the trial in ways they felt would yield the most accurate research results based on their significant experience working with patients with memory loss.
The key element in the study design was ensuring that preliminary testing established a solid cognitive ability baseline for each participant before the drug was administered, Keith said.
"We developed this study in a unique way," he said. "We brought participants in for several testing sessions before they ever received the drug. We carefully tested their cognitive performance to develop a good, solid baseline. The tests were designed to be very sensitive to changes in memory and ability to make complex decisions. We established the baseline, and then repeated the measurements over time."
Allon and its scientific advisory board comprised of some of the leading researchers in the field of Alzheimer's research, considered several alternative proposals for the study design, and ultimately chose the design developed by MARS for the nationwide clinical test of their product.
In addition to designing the study, MARS served as one of the sites for the first round of the national clinical trial. Trials took place simultaneously at 19 other sites, including some of the largest Alzheimer's disease and memory disorder research centers in the nation.
"Our involvement was very exciting," said Keith. "All of the clinical trial sites used the design and protocols that were developed by UNCW faculty working at MARS."
The MARS team worked with each individual participant for about 20 weeks, and the entire clinical study took about a year from design to completion. During the first eight weeks of the study, baseline memory and cognition measurements were obtained for each study participant. The tests were then repeated each month for four months after the participants began receiving the drug (or an inactive placebo) to measure the drug's effects on memory and cognition.
The team worked with Dr. Marsha Fretwell, a Wilmington gerontologist, to recruit patients for the study and tested them at her office.
The drug, called AL-108, was discovered by Israeli researcher Illana Gozes, a major figure in the field of Alzheimer's research. The clinical trials showed that the drug has a positive impact on memory in patients with amnestic mild cognitive impairment (aMCI). The study showed statistically significant effects for patients taking the drug in three types of memory that are clinically relevant in Alzheimer's disease: short-term, working and recognition memory. AL-108 also was found to be safe and well tolerated by patients.
"The hypothesis is that it has strong neuroprotective effects and can protect brain cells from diseases like Alzheimer's," Keith explained. "This is significant because about 80 percent or more of people with mild cognitive impairment will be diagnosed with Alzheimer's disease within six years. They have severe memory loss, so anything that can slow that process is important."
The next steps for this drug are to begin a new series of clinical trials in patients that have already been diagnosed with Alzheimer's disease. Keith said that MARS hopes to continue its involvement in testing AL-108 as well as other drugs that could have potential benefits for stopping or slowing memory loss.
"MARS is all about early detection of memory problems and helping doctors optimize treatment for their patients, so these kinds of studies are a great fit for us," he said.
MARS was formed in 2005 in response to the emerging data showing that new medications can slow the deterioration of memory if they are administered when the first signs of memory loss begin to appear. MARS provides affordable memory screenings to the general population to aid in early diagnosis, works to advance the scientific understanding of memory and memory deficits, and helps to educate the public about memory disorders and their treatment.
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