Alzheimer's Disease (AD) Diagnosis Program – IASOSS.

Alzheimer's disease currently claims over 5,000,000 American lives annually, most of whom are 65 years of age or older and approximately 200,000 are younger. Alzheimer's disease is the most common form of dementia and its most common risk factors are aging and family history. Currently, Alzheimer's disease diagnosis is based on an examination of the patient's history, followed by physical and neurological examinations, including late stage testing which cannot conclusively identify the presence of Alzheimer's disease until followed up by postmortem analysis of the brain. Due to the complex and interrelated nature of dementia diseases, an accurate early stage, noninvasive test that can distinguish Alzheimer's disease from other forms of dementia has eluded the efforts of medical researchers.

We are developing a method (IASOSS) for a blood or fluid based diagnostic device for neurodegenerative diseases, which we believe will be able to identify the early onset of Alzheimer's disease. Our research is based on the measurement of synthesized steroids and accumulated levels of oxidation in the brain which we believe will show a presence in the blood or fluids of humans. We refer to this as our AD Diagnosis Program. Our AD Diagnosis Program is intended to provide a commercially available blood test to determine at an early stage if Alzheimer's disease is present.

Our initial research has identified an oxidative stress mediated pathway for DHEA (dehydroepiandrosterone), a major neurosteroid in the brain, and demonstrated that the analytic procedure we developed may be used to identify steroidal metabolites responding to oxidative stress and their presence or absence from the blood of AD patients when compared to normal controls. The proposed Oxidative-Stress dependent Steroidal metabolite profiling test (OSS-test) will also be tested for its potential ability to diagnose other neurodegenerative diseases linked to increased oxidative stress in brain.

We have conducted initial testing procedures and assays for DHEA, observing differences between patients with Alzheimer's disease and normal controls. The oxidation biochemical test identifies the production of DHEA in blood taken from non-Alzheimer's patients whereas the same oxidation process performed with blood from Alzheimer's patients has minimal effects on DHEA levels. In parallel, we have identified a steroidal signature in the blood specific for individuals with neurodegenerative diseases.

These tests have the potential to revolutionize Alzheimer's disease diagnosis, as we anticipate to establish that they are targeted to diagnose Alzheimer's disease at very early stages and differentiate it from other types of dementia, monitor the effect of therapeutic interventions and the progression of the disease.