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Biomarker Discovery Center Receives Grant to Develop Diagnostic Blood Test

Published: Thursday, January 31, 2013
Last Updated: Thursday, January 31, 2013
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The $799,800 grant from the Osteopathic Heritage Foundation to develop is for a blood test that can diagnose mild cognitive impairment (MCI) caused by early-stage Alzheimer's disease.

MCI affects nearly one in every five adults older than 65, causing memory and language problems beyond those associated with normal aging. Individuals with MCI often exhibit early symptoms of dementia, and approximately 60 percent of all MCI cases are believed to be early-stage Alzheimer’s disease.

The grant from the Osteopathic Heritage Foundation will help expand earlier research conducted by Robert Nagele, PhD, the director of the Biomarker Discovery Center. Dr. Nagele’s published research includes recent findings that identify specific autoantibody biomarkers in the blood that can potentially be used to diagnose early stages of Alzheimer’s and Parkinson’s diseases.

“Using our novel biomarker discovery strategy, we have shown that it is possible to use a single drop of blood to diagnose Alzheimer’s and Parkinson’s with greater than 95 percent accuracy,” said Nagele. “This same approach should also allow us to identify a small number of biomarkers that can also accurately diagnose MCI caused by early-stage Alzheimer’s disease.”

The funded project will pursue three specific goals: identify a small number of autoantibody biomarkers that can accurately (90 percent or higher) diagnose MCI cases caused by early stage Alzheimer’s disease; verify the accuracy rate with a larger scale study; and construct and test a diagnostic kit that is maximally accurate for the broadest possible MCI patient population. If successful, the study will then take the steps needed for final Food and Drug Administration approval of the test.

Current approaches to MCI diagnosis rely on physical, neurological and psychiatric examinations, laboratory tests, and a thorough review of the patient’s medications and medical history. Recently, great attention has been given to using neuroimaging technologies to detect structural changes in the brain before symptoms appear. However, these approaches require expensive equipment and technology and can require hospital visits, the injection of radioactive compounds and the availability of radiologists with advanced training in these techniques.

“A relatively non-invasive test such as ours would allow for early detection of Alzheimer’s-driven MCI, which could lead to beneficial lifestyle changes and improved quality of life, and allow for patients and their families to plan for the future,” Nagele said. “It will also enable physicians to distinguish Alzheimer’s-driven MCI from that caused by other treatable conditions, such as drug reactions, depression or changes to the brain’s supply of blood or oxygen.”

While current treatments for Alzheimer’s cannot stop the progression of the disease, several medications are capable of significantly enhancing brain performance and alleviating symptoms. A number of promising drugs are also currently under development and in clinical trials for the treatment of early Alzheimer’s disease. An easy-to-administer blood test for MCI would give pharmaceutical companies a way to identify patients for clinical trials who are at a very early stage of their disease and give researchers a nearly immediate way to monitor the effectiveness of medications under examination.

The UMDNJ-School of Osteopathic Medicine, the New Jersey Health Foundation, and Durin Technologies, Inc., a biotechnology company with expertise in protein microarray technology, will provide additional support and in-kind contributions of staff, equipment and supplies directly related to this study.

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