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At one point it was thought that the daily use of nonsteroidal anti-inflammatory, painkilling drugs could aid in preventing the cognitive decline associated with the onset of Alzheimer's disease. Prior observation studies had scientists theorizing that anti-inflammatory drugs such as Aleve (naproxen) and Celebrex (celecoxib), may reduce inflammation in the brain. Not so, according to a new trial, which has shown that these medications do nothing to prevent Alzheimer's disease. In fact, naproxen may even have harmful effects on cognitive function.
Researchers conducted tests on cognitive function in more than 2,000 people ages 70 and older who had a family history of Alzheimer's disease. None of the subjects in the study had been diagnosed with the disease. Of the group, 617 people took celecoxib, 596 took naproxen, and 904 took a placebo from March 2001 to December 2004. Six months after they stopped taking the drugs, the medications did not prove any measure of protection for cognitive function and there were indications of detrimental effects, especially for naproxen.
A battery of tests was given to the subjects at the beginning of the study as well as annually. For example, participants were asked to name as many grocery items as they could in one minute. The three groups scored similarly at the start. However, over time, those participants taking Aleve scored slightly lower on average than those who took placebos. The participants taking Celebrex also scored slightly lower than those on the placebo on most of the tests.
The findings of the study were posted online on Monday, May 12. The study was funded by the U.S. National Institute on Aging and will be published in the July issue of Archives of Neurology. According to Barbara Martin, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health and an author of the upcoming article, the interest in the role of anti-inflammatory drugs in Alzheimer's prevention stems from the existence of inflammation in brains of Alzheimer's patients. However, it is unclear as to whether the inflammation is only a symptom of the disease or if it actually contributes to it. Some past observational studies had suggested a positive effect from the drugs, especially ibuprofen, with regards to the prevention of Alzheimer's, yet the randomized and controlled trial has shown otherwise.
The trial was stopped in December 2004, after heightened heart risk was observed with Celebrex in another prevention trial. Researchers also had noticed more heart attacks and strokes in the people taking Aleve in the Alzheimer's prevention study. Tricia McKernan, spokeswoman for Bayer said the early end to the experiment reduces the relevance of the data. She said the findings don't apply to the intended use of Aleve as a short-term pain reliever.
Both naproxen and celecoxib now carry warnings about heart risks and anti-inflammatory drugs can also cause serious gastrointestinal bleeding. Patients are advised to consult their healthcare provider about the length of use of the drugs.
Researchers hope to continue monitoring the participants to see if they find any delayed benefit. Martin says it is possible that more time is needed to observe a positive effect by either taking the drugs longer or allowing more time to pass since having taken them. She also noted that it is also possible that ibuprofen (not included in this study) could be the anti-inflammatory drug with the benefit.
Dr. John Morris, director of the Alzheimer's Disease Research Center at Washington University School of Medicine in St. Louis and a member of the medical and scientific advisory council for the Alzheimer's Association stated, "My strong recommendation is I would not take any drug for a hoped-for effect until it has been demonstrated to have such an effect. Drugs potentially have side effects and unless there's a documented benefit, just because it's popular, I wouldn't rush to do that."
For more information on Alzheimer's disease, visit www.alz.org.
