Study tests pain drugs on dementia

Certain joint pain remedies might stave off Alzheimer's disease. A USF group will take part in a study to test the attractive theory.

By WES ALLISON, Times Staff Writer
© St. Petersburg Times
published February 5, 2002

TAMPA -- The idea is enticing: Common drugs that ease joint pain might also stave off Alzheimer's disease. Now, researchers in Tampa are joining a national study aimed at testing that theory in hopes of finding a simple way to prevent age-related dementia.

The Roskamp Institute of the University of South Florida is one of six U.S. research centers enrolling people with a family history of Alzheimer's for a major study of whether anti-inflammatory drugs may protect against dementia.

Recent research and years of observation suggest they might. This $16-million study is sponsored by the National Institute on Aging at the National Institutes of Health and will follow 2,700 people age 70 or older.

USF hopes to enroll 700 of them.

"This is the last study that one would do before you start saying to people you should be taking nonsteroidal anti-inflammatories," said Dr. Michael Mullan, director of the Roskamp Institute.

"If a simple thing like (this) can prevent the disease, wouldn't that be wonderful? Maybe change the face of the demographic drift toward Alzheimer's."

Several studies, including one published late last year in the New England Journal of Medicine, suggest long-term use of nonsteroidal anti-inflammatories, such as aspirin, ibuprofen and the new class of COX-2 inhibitors, may prevent Alzheimer's or at least lessen its effects.

This is the first placebo-controlled, double-blind study designed to test it. USF is the only site in the Southeast.

Participants will be split into three groups. One will get a placebo. One will get celecoxib, a prescription COX-2 inhibitor sold as Celebrex. The third will get naproxen, an over-the-counter pain reliever sold as Alleve. Both treat the swelling and pain of arthritis.

Participants must be healthy and have a parent or sibling who was diagnosed with serious dementia or Alzheimer's, as well as meet other conditions. They will be followed for five to seven years to see whether one group develops dementia at a lower rate than the others.

Mullan said the theory behind the study is that these drugs may suppress the inflammation caused by certain brain cells, called microglia, that contribute to brain degeneration and memory loss.

The microglia attack the heavy plaque that builds up in the brains of Alzheimer's patients, but they also kill "innocent bystanders" -- the nuerons that carry information, he said. The drugs also may slow the production of this plaque, called beta amyloid protein.

Clinically, doctors have noticed for years that people who take large amounts of nonsteroidal anti-inflammatory drugs, including aspirin, seemed to have some protection against Alzheimer's. Dr. John Breitner, an Alzheimer's researcher at Johns Hopkins University in Baltimore and leader of the study, said 20 large studies suggest that people who take these drugs suffer less from Alzheimer's.

"With a couple of minute twists or wrinkles, they tend to converge quite closely," he said.

Experiments in the lab also show that anti-inflammatories work against the disease. Mullan said mice that have been genetically modified to develop Alzheimer's don't get the disease as severely or as soon if they're given anti-inflammatory drugs.

"If you put them on it early, in the years they should be developing Alzheimer's, they get a much reduced Alzheimer's pathology," he said.

However, experts advised against taking these drugs to prevent Alzheimer's until the results of the study are clear. Many anti-inflammatory drugs can cause severe gastrointestinal problems.

Several NIH studies now under way are studying drugs that may prevent or slow Alzheimer's. In one study, participants are being given ibuprofen. Another national study with sites in Jacksonville, Fort Myers, Tallahassee and South Florida is following women on estrogen.

In the recent New England Journal of Medicine study, published in November, Dutch researchers reported that use of arthritis medicines such as ibuprofen for more than two years reduced the risk of Alzheimer's disease by up to 80 percent.

Breitner said he thinks this study will help answer the question.

"The bad news is it's going to take a long time to get the answer," he said. "The good news is that the preliminary data (from other studies) is very encouraging."

Want to participate?

The University of South Florida is recruiting people for a national Alzheimer's prevention trial. Participants must be at least 70 years old, have a parent or sibling who was diagnosed with Alzheimer's and be in of good health.

To learn more, call the Roskamp Institute at USF at (813) 974-3100.

For more information about Alzheimer's trials, go to www.alzheimers.org, a service of the National Institute on Aging.

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