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.
Media contacts:Dr. Julian Keith, professor of psychology, 910.962.3378 or firstname.lastname@example.org
Dana Fischetti | newswise
Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)
The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft
Salmonellae are dangerous pathogens that enter the body via contaminated food and can cause severe infections. But these bacteria are also known to target...
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
23.10.2017 | Event News
17.10.2017 | Event News
10.10.2017 | Event News
24.10.2017 | Life Sciences
23.10.2017 | Life Sciences
23.10.2017 | Physics and Astronomy