According to Dr. John DeBernardis, President and CEO of Applied NeuroSolutions and a co-author of the study, "Finding a biomarker that effectively predicts who will get Alzheimer's disease has been considered the Holy Grail of Alzheimer's research for many years. We now believe that variations in the levels of p-tau 231 (tau protein phosphorylated on amino acid 231) may be used to effectively predict structural progression of Alzheimer's disease."
Harald Hampel, M.D., of the Alzheimer Memorial Center and Geriatric Psychiatric Branch of the Department of Psychiatry at Ludwig-Maximilian University in Munich, Germany was the lead investigator of the study. The data in the study agree with the notion that variations in p-tau 231 levels reflect differences in the degree of neuronal damage across AD patients, thus, p-tau 231 levels may be used to predict progression of brain atrophy in AD patients.
In the study of 22 Alzheimer's disease patients, all underwent Magnetic Resonance Imaging (MRI) to image the brain and had CSF samples taken. Levels of p-tau 231 predicted the rate of subsequent hippocampal atrophy as measured by MRI. In contrast, levels of total tau, another biomarker also used in the study, did not. In the end, higher p-tau 231 levels were found to correspond with higher rates of neuronal degeneration of the hippocampus.
In numerous other studies, the p-tau 231 assay developed by Applied NeuroSolutions has been shown to discriminate Alzheimer's disease patients from patients with other neurodegenerative disorders. Currently there is no FDA-approved diagnostic test for Alzheimer's disease. The market for an effective, easy to use, AD diagnostic test has been estimated to be approximately $5 billion.
Applied NeuroSolutions, Inc. is developing products to diagnose and treat Alzheimer's disease based on a novel hypothesis of AD cause and 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 more than 3,000 patient samples. 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.
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.