Oral Therapy using Anti-Oxidants for Alzheimer's Disease
DESCRIPTION (provided by applicant): Nanotherapeutics proposes to evaluate oral taurine therapy for Alzheimer's disease (AD). AD, the most common form of dementia among older people, affects over 4 million Americans. It requires full-time care in the end stages and is a significant financial burden on the health care system. Oxidative stress is believed to play a major role in the pathogenesis of AD. Studies have shown that taurine, an aqueous-soluble non-essential amino acid, reduces in levels with age in the brain, plasma, and CSF and are also significantly decreased in Alzheimer's patients. Even though taurine has not been evaluated in clinical trials for AD, the literature strongly suggests that it can reduce oxidative markers found in AD. Related research has also shown that vitamin E slows the progress of some cognitive deterioration of AD by approximately 7 months, possibly due to its antioxidant activity, thus taurine may provide similar benefits. While there is substantial effort in finding new drugs to combat the disease, there is also growing interest to evaluate vitamins and nutraceuticals with long-standing safety histories as an alternative therapy to new drugs, which may take several years in clinical trials to reach the market. We proposed novel formulations of the antioxidant taurine might be excellent candidates for therapeutic use in AD. Oral absorption of taurine has been reported to be poor; however; using our proprietary Nanodry TM and Nanocoat TM processes, testing to improve the bioavailability is proposed. Therefore, a significant amount of work in this proposal is to (1) improve the oral absorption of the antioxidant taurine towards (2) reducing the formation of beta-amyloid plaques implicated in Alzheimer's disease. The hypothesis of this proposal is that oral administration of taurine, potentially through the development of improved oral nanoparticle formulations, may be able to protect against formation of plaques and potentially the onset of Alzheimer's disease. Specifically, we will:
1. Evaluate different formulations of taurine in vitro for efficiency in producing nanoparticles and assess dispersion properties and release-rate. 2. Determine the bioavailability and the ability of taurine formulations to suppress lipid peroxidation in rats. 3. Determine the ability of oral administration of taurine formulations to reduce plaque formation in vivo in transgenic plaque-forming mice. 4. Establish the milestones and experimental approaches for the Phase II studies.
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NANOTHERAPEUTICS, INC. 12085 RESEARCH DR, STE N ALACHUA, FL 32615
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