Study Shows Applied NeuroSolutions' Test Is A Significant Predictor Of The Decline From Mild Cognitive Impairment To Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Also Included In: Neurology / Neuroscience
Article Date: 20 Dec 2007 - 3:00 PDT

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Applied NeuroSolutions, Inc (OTC BB:APNS), a Company focused on the development of an integrated portfolio of products for the treatment and diagnosis of Alzheimer's disease (AD), reported that a peer-reviewed paper, "Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI," is highlighted as a featured study in the December 11, 2007 issue of the print edition of Neurology. APNS's p-tau 231 biomarker (p-tau 231) was utilized in an international, multicenter study, led by Dr. Harald Hampel, and shown to be a significant predictor of conversion in the transition from mild cognitive impairment (MCI) to Alzheimer's disease in a relatively short and clinically relevant observation interval.

Mild cognitive impairment is a predementia risk state for the possible development of Alzheimer's disease. Research literature indicates that approximately 16% of individuals with MCI develop AD annually, however the conversion rate may be as high as 41% after one year and 64% after two years while some patients may never convert to Alzheimer's disease and some may return to normal.

In this longitudinal, European based multicenter study, 145 subjects were followed for 1.5 years on average, including forty-three MCI subjects that subsequently declined to AD, forty-five MCI subjects that did not decline to Alzheimer's disease and fifty-seven controls. The results of the study suggest clinical utility of p-tau 231 for the prediction of Alzheimer's disease within a clinically useful time period of 1.5 years. The APNS p-tau 231 biomarker was a reliable predictor of conversion to AD regardless of the baseline cognitive score as measured by MMSE.

Harald Hampel, M.D., Professor and Chair of Psychiatry at Trinity College in Dublin, Ireland and head of the Alzheimer Memorial Center at Ludwig-Maximilian University in Munich, Germany was the lead investigator of the study. Dr. Hampel commented "This is one of the first multicenter controlled validation studies on early detection and prediction of Alzheimer's disease and the first one using p-tau 231. It is key to note that we utilized an assessment period of 1-2 years, which is both relatively short and a clinically relevant time frame for the prediction of disease progression to Alzheimer's disease. This marker could become pivotal to allow for early intervention and support best possible outcomes. In our seminal study we show for the first time that a standardized criterion of hyperphosphorylated tau assessed in CSF is feasible for the early detection and prediction of Alzheimer's disease across different international memory clinics. In this retrospective study we found that CSF-levels of p-tau 231 predict the conversion from preclinical mild cognitive impairment to Alzheimer's disease with an accuracy of about 80% across clinics in a relatively short and clinically useful time frame, which meets the consensus criterion of an ideal biomarker for Alzheimer's disease. These results strongly indicate that APNS's CSF-based p-tau 231 may be relevant to aid in the early detection of Alzheimer's disease in clinical diagnostics, particularly in the advent of novel disease modifying Alzheimer's disease treatments currently in the last stages of clinical development in international trials. We look forward to the establishment of this predictive biomarker to enable the new generation of AD drugs to be administered in pre-dementia stages of the disease when patients would benefit much more from earlier therapy."

"APNS's goal in developing diagnostics is to provide accurate and early support in the identification of Alzheimer's disease to offer the best opportunity for patients to take full advantage of available treatment options. We feel it is important to continue to build on our previously published MCI data and we are pleased that this study provides important additional evidence that our CSF-based test has strong predictability to aid in the diagnosis of AD for the large and fast growing global MCI population," said Ellen R. Hoffing, Applied NeuroSolutions President and CEO. "In addition to the progress we have made on our CSF-based test to address its applicability to the MCI population, we are also developing serum-based tests to diagnose Alzheimer's disease in its early stages."

About Applied NeuroSolutions

Applied NeuroSolutions, Inc. (OTC BB:APNS - News) is developing diagnostics to detect Alzheimer's disease (AD) based on discoveries originating from the Albert Einstein College of Medicine and, in collaboration with Eli Lilly and Company, is developing novel therapeutic compounds to treat the progression of the disease. Applied NeuroSolutions is pursuing biomarkers that the company believes will aid in the development of effective AD treatments. Applied NeuroSolutions is focused on both a cerebrospinal fluid (CSF) diagnostic test and blood tests to detect AD at a very early stage. The CSF test can already differentiate AD patients from those with other diseases that have similar symptoms. There is currently no FDA approved diagnostic test to detect Alzheimer's disease. Alzheimer's disease currently afflicts over five million Americans, and the world market for AD therapy is currently estimated to be 30 million patients.

http://www.appliedneurosolutions.com

This press release contains forward-looking statements about Applied NeuroSolutions. The company 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.

Applied NeuroSolutions, Inc