More than 4.5 million Americans currently suffer from Alzheimer's Disease, a progressive neurodegenerative disease characterized by loss of memory, changes in personality, agitation, disorientation, loss of coordination, and finally, total loss of day-to-day functioning. Alzheimer's is a staggeringly expensive disease, costing the American economy more than $83.9 billion annually. The Alzheimer's Association estimates that by 2050 between 11.3 million and 16 million Americans will be Alzheimer's victims and that the overall economic impact of the disease will increase 4-fold. Much of the cost of Alzheimer's is born by Medicare and Medicaid. There is currently no treatment that halts the overall progression of the disease. As such, there is a great need for a significant breakthrough in Alzheimer's prevention and treatment. There is a growing consensus that Alzheimer's is a multifactorial disease and it is possible that a """"""""cocktail"""""""" of medicines or ingredients may be needed to successfully delay its onset or progression. The overall goal of this Phase I SBIR proposal is to formulate and conduct initial feasibility tests of a medical food cocktail composed of standardized herbal extracts, vitamins, and minerals that are demonstrated in the basic science and clinical medical literature to impact the biochemical and pathophysiological processes involved in Alzheimer's Disease. The first Specific Aim will be to formulate and standardize the cocktail, which will include extracts of tumeric, green tea, black pepper and vitamins and other nutritive ingredients. Once formulated, the second Specific Aim will be to test the effects of the cocktail on biochemical markers and immunohistochemistry related to neurodegeneration in a novel transgenic mouse model of Alzheimer's Disease that was developed at the University of California-Irvine. Plans for Phase II of the project include more extensive pre-clinical testing of the cocktail in mice, as well as clinical studies on the effect of the cocktail on cognitive functioning and markers for Alzheimer's Disease processes in humans, at the early stages of the disease. If such a medical food cocktail proves feasible and cost effective for use as a complementary or alternative therapy for Alzheimer's Disease, the devastating economical and societal costs of Alzheimer's may be drastically reduced. ? ?
