a. Field of the Invention
The present invention relates generally to methods for the treatment of multiple sclerosis and other neurodegenerative diseases, disorders and conditions, and more particularly to treatment of such multiple neurodegenerative diseases, disorders and conditions by administration of an alkyl ester of imidazole carboxylic acid in order to maintain the intracellular/extracellular osmolyte gradient in the central nervous system (CNS).
b. Background
Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system resulting in sensory and motor dysfunction, visual disturbances, cognitive and memory impairment, and bowel and bladder dysfunction. Multiple sclerosis is the most common neurological disorder of young adults with the onset of symptoms generally occurring between the ages of 20 and 50. According to the National Multiple Sclerosis Society, the disease currently affects more than 400,000 individuals in the United States with 200 new cases diagnosed every week and more than 2.5 million people worldwide. Data from the recent Zogby International poll suggests that these numbers are underestimated and that multiple sclerosis affects 2.87 million individuals in the United States and more than 6.25 million worldwide. Over 70% of all multiple sclerosis patients are too disabled to remain in the workforce due to symptoms of fatigue and cognitive dysfunction. A recent study by Duke University estimates annual direct and indirect costs of MS in the United States to be $9 billion; this makes it second only to Alzheimer's disease in economic impact.
The cause of multiple sclerosis still eludes science, but it has been postulated that it is an autoimmune disease in which the immune system attacks and destroys the myelin in the central nervous system. Thus, the FDA approved medications for multiple sclerosis are all aimed at suppressing the immune system, but unfortunately these treatments have failed to have any beneficial effect on the debilitating symptoms associated with multiple sclerosis. Recent research published in 2002 by Dr. Behan, Professor Emeritus of Clinical Neurology, and colleagues, shows that multiple sclerosis is not an autoimmune disease in which the immune system is attacking the myelin. Behan et al, proved via MR Spectroscopy that the oligodendrocytes (the myelin producing cells in the central nervous system) underwent degeneration up to three weeks before any immune cells were present at the site of degeneration.
In addition to MS, there are many other neurological diseases and disorders that may stem from possibly similar degenerative mechanisms. Examples include, but are not limited to, fibromyalgia, memory impairment, and certain forms of depression and erectile dysfunction.
Accordingly, there exists a need for a method for treating neurodegenerative diseases, disorders and conditions, such as multiple sclerosis, that yields beneficial results, and that is not founded on the previous autoimmune hypothesis. Furthermore, there exists a need for such a method that yields rapid, substantial and sustained benefits to patients. Still further, there is this need for such a method in which the treatment can be applied to patients on an economical basis and without undue difficulty.
USPTO Backgrounds
USPTO Backgrounds