Volunteers needed to test drug that may prevent, treat Alzheimer's disease

Monday, January 27, 2003

JACKSONVILLE, Fla., Jan 27, 2003 — Researchers at Mayo Clinic in Jacksonville, Fla., are recruiting volunteers 55 to 80 years old to participate in a study of a medication that decreases the level of amyloid beta, a protein known to play an important role in developing Alzheimer's disease.

Many researchers and drug companies around the world now believe that decreasing the amyloid beta protein may treat or even prevent Alzheimer's disease. Researchers from Mayo Clinic in Jacksonville and the University of California, San Diego (UCSD) found that some, but not all, commonly used non-steroidal anti-inflammatories (NSAIDs) decrease this protein in cell cultures and experimental animals. Several epidemiological studies have also shown that patients who take these medications have less chance of developing Alzheimer's disease.

A common side effect of NSAIDs is gastrointestinal bleeding. However, the Mayo Clinic and UCSD researchers found that a part of an existing Food and Drug Administration-approved NSAID medication decreases amyloid beta in animals with theoretically less gastrointestinal side effects. This is the compound they will be studying in a National Institutes of Health and Myriad Pharmaceuticals-sponsored clinical trial.

Volunteers must not have any memory difficulty, and they must not have an ulcer or bleeding from the gastrointestinal tract. They must not be taking statin drugs to lower cholesterol such as Mevacor, Zocor or Lipitor, and they must be willing to forgo aspirin use for four weeks. In addition, volunteers must be willing to have blood tests and a lumbar puncture at the beginning and at the end of the study to measure the level of the study drug and its effect on the amyloid beta protein level in the blood and spinal fluid.

Dr. Neill Graff-Radford is one of the study investigators and chair of the Department of Neurology at Mayo Clinic in Jacksonville. He says the first goal of the study is to determine if the medication is safe at different doses in people and if it lowers the amyloid beta protein in blood and spinal fluid. "If we can show that the medication is safe and that it lowers the amyloid beta protein," Graff-Radford says, "we plan to go onto trials with it at different stages in the evolution of Alzheimer's disease, that is, from prevention to the disease itself."

Although research into the use of presently used NSAIDs for Alzheimer's disease is interesting, Graff-Radford cautions against prolonged use of these medications without consulting a physician.

Those interested in participating in the study may call (904) 953-8634.

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