In a pilot study, published in the March /April issue of the American Journal of Geriatric Psychiatry the Georgetown researchers--led by Paul S. Aisen, M.D., professor of neurology, and principal investigator of the ongoing multi-center trial--found that high dose vitamins reduce levels of the amino acid homocysteine in individuals with Alzheimer's disease. Previous studies have linked homocysteine to Alzheimer's disease. Investigators at Columbia University, University of Texas, Southwestern and University of California, Davis also participated in the pilot study.
"Individuals with Alzheimer's disease have higher levels of homocysteine than people of similar age who do not have the disease," said Dr. Aisen. "In our vitamin pilot study we have demonstrated that we are able to reduce levels of homocysteine using a vitamin regimen that is both safe and inexpensive. Now we are conducting a therapeutic trial to determine whether use of the vitamins folic acid, B12 and B6 to lower homocysteine level has a favorable impact on the course of the disease."
The multicenter vitamin study, known as Vital (VITamins to Slow Alzheimer's Disease), funded by the National Institute on Aging, has just begun recruiting patients across the country. Four hundred individuals with mild to moderate Alzheimer's disease will be randomly assigned to receive vitamins or placebos. An assessment of their cognitive function – memory, thinking and language – will be made to determine the progress of their disease during the course of 18 months.
Dr. Aisen, who designed and oversees VITAL, views the recently published pilot study as the first step in the development of a potentially important way of slowing the course of Alzheimer's disease. But he cautions, "We are not suggesting that people go out and take high doses of these vitamins. There are possible downsides, including peripheral nerve damage. The multi-site therapeutic trial will show us whether high doses of folic acid, B12 and B6 can indeed slow down the progression of Alzheimer's disease and become an important therapy for a devastating disease that affects 4 million Americans."
Family members of individuals with mild to moderate Alzheimer's disease in the Washington, DC area who are interested in participating in the trial at Georgetown should contact the Memory Disorders Program at 202-784-6671.
Other study sites for the clinical trial are located in Alabama, Arizona, California , Connecticut, DC, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, and Texas. A complete list with contact information can be found at http://www.alzheimers.org/dbtw-wpd/exec/dbtwpcgi.exe?AC=GET_RECORD&XC=/dbtw-wpd/exec/dbtwpcgi.exe&BU=http%3A%2F%2Fwww.alzheimers.org%2Ftrials%2Fbasicsearch.html&TN=trials3&SN=AUTO4692&SE=1029&RN=2&MR=20&RF=Titles&DF=Full-Records&RL=1&DL=1&NP=1&ID=&MF=&MQ=&TI=0
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis--or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, and the world renowned Lombardi Cancer Center.
Journal
American Journal of Geriatric Psychiatry