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Increase in Specific, Abnormal Brain Protein May Predict Onset of Alzheimer's Disease, Study Shows

Posted on: Thursday, 5 January 2006, 15:00 CST

An increase in a specific, abnormal brain protein appears to herald the onset of Alzheimer's disease (AD), according to a study soon to be published in Neurobiology of Aging.

The study, led by Dr. Vahram Haroutunian (Department of Psychiatry, The Mount Sinai School of Medicine) and Applied NeuroSolutions' founding scientist, Dr. Peter Davies of Albert Einstein College of Medicine, in conjunction with leading experts in the area of tau pathology and Alzheimer's disease, noted a correlation between the increasing levels of the tau protein in the brain with a rise in the severity of dementia and cognitive impairment. This increased level of tau protein appeared prior to the development of neurofibrillary tangles (NFT), which are the hallmark lesions of Alzheimer's disease.

The study analyzed post-mortem brain tissue samples of 81 people, ranging from those with no indication of cognitive impairment to those diagnosed with AD. There is currently no FDA-approved diagnostic test for AD. AD can only be definitively diagnosed through post-mortem studies.

Applied NeuroSolutions is seeking to commercialize a diagnostic test to detect AD that measures the amount of an abnormal protein, called p-tau 231 (tau protein). In testing of nearly 3,500 samples, the assay has proven to be 85-95 percent sensitive and specific in detecting AD.

"This study is one of many that provides evidence of the link between the presence of the tau protein and AD, and further validates our technology platform," said John DeBernardis, Ph.D., President and CEO of Applied NeuroSolutions. "We are working diligently to provide the FDA with the necessary materials to begin clinical trials on our lead diagnostic test in 2006."

About Applied NeuroSolutions

Applied NeuroSolutions, Inc. (OTCBB:APNS) is developing products to diagnose and treat Alzheimer's disease based on a novel hypothesis of AD pathology. In partnership with Dr. Peter Davies and a scientific team at Albert Einstein College of Medicine, Applied NeuroSolutions has developed a cerebrospinal fluid (CSF) test to detect Alzheimer's disease at a very early stage with 85%-95% accuracy in nearly 3,500 patient samples. There are approximately 2 million new patients annually worldwide who are candidates for an AD CSF diagnostic test, according to Datamonitor. The company is also developing a blood serum-based screening test, as well as a new class of therapeutics to treat AD. Alzheimer's disease currently afflicts over 4 million Americans, and the market for AD therapy is expected to grow to 21 million patients by 2010 in the seven major pharmaceutical markets (USA, France, Germany, Italy, Spain, U.K. and Japan) according to BioPortfolio, Ltd. For more information, visit www.appliedneurosolutions.com.

There are currently no FDA-approved diagnostic tests to detect Alzheimer's disease.

This press release contains forward-looking statements. Applied NeuroSolutions wishes to caution the readers of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, the risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, potential competitive offerings, and access to capital. For further information, please visit the company's website at www.appliedneurosolutions.com, and review the company's filings with the Securities and Exchange Commission.

Source: Business Wire

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