On April 24, 2006, a clinical trial using one of the newest drugs, Alzhemed was found to reduce dementia in four out of nine patients who were involved in the trial. The drug works to reducing the abnormal amyloid/ plaque clumps and bundles of neurofibrillary tangles in the blood vessels in the brain. Alzheimer’s, as you recall, is a progressive neurodegenerative disease that results in the development of amyloid plaque and tangles that form in the brain. Age appears to be a factor as is a genetic predisposition to the disease. Three genes for the disease have already been identified that can cause early onset of the disease. Symptoms of the disease include memory loss, language deterioration, impaired ability to mentally manipulate visual information, poor judgment, confusion, restlessness and mood swings.
Unfortunately, the number of people with the disease doubles every five years after age 65 (National Institute on Neurological Disorders and Stroke). There are 5.1 million individuals in the United States who have the disease. The longer a person lives, the greater the risk. One in eight over 65 has it, and half of those over 85 are afflicted with the disease. The estimates by the year 2025 are that over 22 million individuals worldwide will be afflicted.
Paul Aisen, MD, professor of neurology and medicine at Georgetown University Medical Center and principal investigator in the United States of the ongoing Phase III clinical trial tranmiprosate (Alzhemed), says that "Developing successful treatment to slow the progression of this disease, which today remains an unmet medical need, would be a major advance in the fields of neurology and age-related illnesses." Since Phase II of the trial using Alzhemed; the drug continues to show clinically significant benefits on cognitive and global performance measures. Stabilization of the disease was noted in four out of nine mildly affected patients, after three yeas of treatment. For the first time, the laboratory results, presented by Dr. Aisen, are reported on the actual mechanism and action of Alzhemed. In the disease process, beta-amyloid collects between the nerve cells, disrupting brain function and that triggers an immune response that destroys the cells. Beta-amyloid in the form of plaque and tangles are found in the damaged brain cells. The result of this disrupts brain function and triggers an immune response that destroys brain cells. The cause is still unknown. In the clinical trials so far, the drug appears to have a protective effect on brain cells and seems to prevent formation of plaque in the cells.
Phase III of the trial involves 1,052 patients with mild to moderate Alzheimer’s disease (AD), at more than 70 clinical sites throughout the United States and Canada. The trial ended in January of this year.There are also ongoing trials in Europe with about 900 mild to moderate AD patients.
There are more than four dozen other drugs now in human clinical trials. One of the most promising is Flurizan, from Myriad Genetics. Researchers should complete testing in the next 18 months. Experts say that these drug trials are the results of over 20 years of scientific work on Alzheimer’s. The director of the AD center at University of California at San Diego, Douglas Gailasko,M.D., concurs that "We are now at a point where we understand enough about the molecules and mechanism of the disease to target new therapies very, very precisely."
Sometime this month (closing in on Alzheimer’s/AARP Bulletin, June 2007), scientists are expected to present the final test results for the newest generation of drugs designed to attack the underlying cause of the disease. Sam Gandy, chair of the National Medical and Scientific Advisory Council of the Alzheimer’s Association and director of the Farber Institute for Neurosciences in Philadelphia, says, "Within three years, it is all but certain that we’ll have disease-modifying drugs that fundamentally change the nature of Alzheimer’s."
Finally, there is hope. With this exciting news, there may be many more aging men and women who will be living longer and healthier, and without Alzheimer’s Disease. Scientists continue to unwind the mystery of who may become victims so that the disease could be arrested in its early stages before damage occurs. For information on clinical trials in your area, call 1-800-438-4380, the government’s AD Education and Referral Center, or online, www.nia.nih.gov/Alzheimers .