Applied Neuro Solutions
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Company Contact: John F. DeBernardis, Ph.D., President and CEO
(847) 573-8025 ext. 264

Agency Contact: Ira Weingarten/Steve Chizzik
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(805) 897-1880

Media Contact: Deanne Eagle
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Vernon Hills, IL, September 30, 2004 - An assay developed by Applied NeuroSolutions (OTC BB: APNS, when combined with MRI (Magnetic Resonance Imaging), was shown to identify neural signposts in patients with mild cognitive impairment (MCI), a condition known to increase the risk of developing Alzheimer’s disease (AD), according to a study published this month in the Journal of Internal Medicine.

In a one year longitudinal study of eighteen patients, ten of which were classified as normal elderly and eight of which were MCI, high levels of the p-tau 231 biomarker distinguished the groups and was found to correlate with the hippocampal volumes as measured by MRI. Hippocampal atrophy is one feature of Alzheimer’s, but along with memory changes can also appear in other neurological diseases. The p-tau 231 assay, which measures elevated levels of tau protein phosphorylated on amino acid threonine at position 231, has been shown to specifically indicate Alzheimer’s disease in previous studies. Together, these two modalities do a better job of diagnosing AD than current diagnostic approaches.

According to Dr. Mony de Leon, “the interim results reported in this paper demonstrate some of the earliest detectable evidence of the brain changes that signal Alzheimer’s disease.” A very promising feature of this work is the potential for the APNS biomarker to add to the diagnostic specificity of the early diagnosis. The atrophy found on MRI scans and the memory loss detected in the clinic may be due to a multiple number of causes. When these examinations are combined with the biomarker there is potential for increasing confidence in the early diagnosis of AD concluded Dr. de Leon, Professor of Psychiatry at the New York University.

In addition, according to lead investigator Dr. Mony de Leon, using MRI to estimate and to correct for the progressive longitudinal increases in the water content of the brain, it was shown that the APNS biomarker demonstrated longitudinal effects that were of diagnostic significance. These results suggest that the biomarker could be considered as potential outcome measures in clinical trials.

According to Dr. John DeBernardis, President and CEO of Applied NeuroSolutions and a co-author of the study, “Our hope is that early detection can become the linchpin of a strategy that enables the medical community to identify earlier points for therapeutic intervention in this horrible disease. Today’s results, though still preliminary, tell us that an effective and affordable approach to early detection is indeed possible.“ There is currently no FDA approved diagnostic test for Alzheimer’s disease.

Applied NeuroSolutions, Inc. is developing products to diagnose and treat Alzheimer’s disease based on a novel theory of AD cause and pathology. In partnership with Dr. Peter Davies and a scientific team at Albert Einstein College of Medicine, Applied NeuroSolutions’ initial product candidate is a cerebrospinal fluid (CSF) test to detect Alzheimer's disease at a very early stage with 85%-95% accuracy. The company is also developing a serum-based screening test, as well as a new class of therapeutics to treat AD. Alzheimer’s disease currently afflicts over 4 million Americans, with that number expected to grow to 14 million by 2050. Currently, there is no FDA-approved diagnostic test to detect Alzheimer’s disease available.

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, and review the company's filings with the Securities and Exchange Commission.