Apr 15 2004
In a small clinical trial enrolling 63 individuals with Alzheimer’s disease, half of those who received atorvastatin (Lipitor) stabilized or improved after one year of treatment, the trial’s principal investigator D. Larry Sparks, Ph.D., reported today at a professional meeting on Alzheimer therapy.
“We are always pleased to see a positive clinical trial,” said William H. Thies, Ph.D., Alzheimer’s Association vice president, Medical and Scientific Affairs. “Obviously, larger-scale trials are needed to confirm these initial encouraging results, and several of those are under way. We expect to hear more about this area at the Alzheimer’s Association 9th International Research Conference on Alzheimer’s Disease and Related Disorders this July in Philadelphia.”
“As with all early reports, this one does not represent a call for widespread statin therapy for Alzheimer’s disease. Any change in medication should always be carefully reviewed with a person’s physician.”
The trial data, although encouraging, have not yet been reviewed by independent experts. The study was sponsored by the Institute for the Study on Aging and Pfizer Inc, atorvastatin’s manufacturer.
Atorvastatin is one of the statins, a class of drugs approved by the U.S. Food and Drug Administration (FDA) to lower cholesterol levels. Epidemiological studies have suggested that individuals taking statins to treat high cholesterol seem to have a reduced risk of developing Alzheimer’s disease. This kind of observation needs to be confirmed in clinical trials specifically designed to test the effect of statins on Alzheimer’s, because observational studies can hint that a relationship between a treatment and an outcome exists but cannot prove cause and effect.
This trial enrolled individuals 50 years of age and older who had been diagnosed with Alzheimer’s and scored from 12 – 28 points on the Mini-Mental State Exam (MMSE), a widely used 30-point test of cognitive function. Compared with participants who received the placebo, those who received atorvastatin performed better after one year of treatment on both the MMSE and the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), another widely used test.
Participants who at the time of enrollment were taking a cholinesterase inhibitor, one of the two types of drug specifically approved by the U.S. FDA to treat Alzheimer symptoms, were allowed to continue to take that medication as long as they had been on a stable dose for at least three months. No participant was permitted to begin taking a cholinesterase inhibitor after enrolling.
Dr. Sparks reported trial results at the 8th International Montreal/Springfield Symposium on Advances in Alzheimer’s Therapy in Montreal.