NeuroQuest Development Center, Inc., today announced they have entered into a service agreement with the University of California, San Diego for collection and processing of blood samples for their U.S. clinical validation trials.
The South Carolina-based biotech company is developing a blood test for early diagnosis of Alzheimer's disease (AD).
Designed to be an inexpensive, convenient surrogate test for costly positron emission tomography (PET) brain scans, the NeuroQuest blood test can potentially identify a pre-clinical stage of AD in a person years before the onset of noticeable symptoms.
Recent pilot testing of NeuroQuest's biomarker technology in Australia surpassed current standards of specificity and sensitivity set by the U.S. Alzheimer's Association.
"Based on our pilot test results, we are cautiously optimistic about our upcoming U.S. clinical trials," said Dan Touitou, CEO of NeuroQuest. "The larger scope of the Anti-Amyloid in Asymptomatic AD (A4) study will greatly help us determine the validity of our science."
The A4 study, funded by the National Institute on Aging, Eli Lilly and Company, and several philanthropic organizations, is a national clinical trial for older individuals who may be at risk for AD.
To assist with their U.S. clinical trials, NeuroQuest has contracted with Robert Rissman, Ph.D., assistant professor in the Department of Neurosciences and Biomarker Core Director for the Alzheimer's Disease Cooperative Study (ADCS) at University of California, San Diego.
Rissman will oversee the processing and testing of blood samples from 700 asymptomatic study participants, primarily from screening visits of the A4 study.
To qualify for the A4 study, subjects who are free of memory impairments must have evidence of beta amyloid accumulation based on PET scans. Beta amyloid accumulation, or amyloid brain plaque, is considered to be one of the root causes of AD.
"By focusing on early screening samples from A4, NeuroQuest will be able to get a cross section of both asymptomatic AD patients and control subjects," said Rissman.
The ability to identify a Alzheimer's in a person years before the onset of noticeable symptoms will allow for earlier clinical intervention and pave the way for new therapies and research.
Validation studies for NeuroQuest's diagnostic blood test will continue in Australia and the U.S. through 2017.
The blood test is based on the principles of protective autoimmunity and nearly 20 years of award-winning research led by Professor Michal Schwartz, Chair and vice president of the international society of Neuroscience, the Weizmann Institute in Israel.
Worldwide, nearly 44 million people have Alzheimer's or a related dementia. In the U.S., 5.3 million people are living with Alzheimer's. To date, no objective, accurate, cost-effective and practical tool for early diagnosing Alzheimer's exists.