New Drug Fails to Provide Boost in Early Alzheimer’s...

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June 4, 2003

June 4, 2003

A major report in today's Journal of the American Medical Association found that two popular painkillers did nothing to slow the progression of Alzheimer's disease in people with mild to moderate decline. The study, the most rigorous to date, dampened hopes that anti-inflammatory drugs may be an effective treatment for this devastating mind-robbing ailment.

It remains unknown, however, whether these or related drugs may have some benefits in preventing the illness in the first place if given to people before the onset of symptoms.

The trial looked at two popular anti-inflammatories. One of these was naproxen, sold over-the-counter in pharmacies as Aleve. The other was a prescription drug called rofecoxib, or Vioxx, a potentially safer type of medication known as a COX-2 inhibitor. The two belong to a group of inflammation-fighting pain relievers referred to as nonsteroidal anti-inflammatory drugs, or NSAIDs, that are commonly taken to ease arthritis.

The study recruited 351 patients, average age of 73 to 74, with mild to moderate Alzheimer's disease. A third took naproxen (25 mg once a day), a third took Vioxx (220 mg twice daily), and the remaining volunteers received look-alike dummy pills. Those people who were already taking Alzheimer's drugs , estrogen, low-dose aspirin, or vitamin E were allowed to keep taking them.

After a year, those taking the NSAIDs did no better than those receiving a placebo. Tests of memory and language skills revealed that symptoms progressed at the same rate in all patients. The study volunteers were also assessed for mood and their ability to perform everyday tasks like shopping and using the telephone, but no group showed any benefits over the other.

Many patients with Alzheimer's take these drugs in the hopes of relieving symptoms. However, they can cause digestive upset and more serious side effects, including bleeding in the stomach or kidney problems. Six people in the current study developed serious bleeding in reaction to the drugs.

Because of such side effects, many doctors have long advised that these drugs not be taken to treat Alzheimer's until further evidence is in. Today's study firmly bolsters those recommendations.

Hope Remains

Scientists had been hopeful that this class of drugs might have some effectiveness as a treatment against Alzheimer's. Inflammation appears to play a role in the death of brain cells in people with disease, although it is unknown whether this is a cause or an effect of the illness. In addition, studies in mice have found that anti-inflammatories can prevent the buildup of plaque, the toxic substance that builds up in the brains of those with Alzheimer's.

Still, researchers are not ready to give up on this class of drugs. It is possible that those taking different anti-inflammatories or higher doses might show benefits. More studies are under way.

Surveys have also found that NSAIDs may have benefits for preventing Alzheimer's in the first place. In population surveys, people who had taken these arthritis medications for years were less likely to develop the mind-robbing illness. Because Alzheimer's may take years or even decades to develop, some doctors argue that the drugs may be effective if given earlier, before alteration in the brain have progressed too far. A large seven-year study by the National Institutes of Health is under way to test this theory.

Like all drugs, however, anti-inflammatories remain potent medicine, with potentially life-threatening adverse reactions in some people. Therefore, it is always important you consult with your doctor before using them.

More potent drugs that work against toxic amyloid, the substance that contributes to plaque buildup and that is thought to be key to Alzheimer's, are also under investigation.

By Toby Bilanow, Medical Writer for www.ALZinfo.org. The Alzheimer’s Information Site.

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