Pilot study of Lipitor hints at benefit
A small pilot study of 63 individuals with mild to moderate Alzheimer's disease suggests that those taking 80 milligrams of atorvastatin (Lipitor) daily for one year tended to do better on tests of memory and thinking than those receiving a placebo. These results are reported by D. Larry Sparks, Ph.D., and colleagues in the May Archives of Neurology.
The study also found caregivers tended to feel as if participants on atorvastatin were doing better than those on the placebo. Neither positive effect reached statistical criteria for having a high likelihood of being due to the effects of the medication rather than to chance at the end of the study, although the benefit for memory and thinking came close.
"In a study as small as this one, you don't expect to see very significant differences in treatment compared with placebo, so the positive tendencies are encouraging," notes William H. Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "The other good sign is that for this small group, giving atorvastatin to individuals with normal cholesterol levels seems fairly safe. The message here is not that anyone with Alzheimer's disease should start taking atorvastatin or any other statin based on these findings, but there's enough evidence to justify conducting a larger clinical trial to see if the benefits hold up."
A large federally funded trial of simvastatin (Zocor), another statin, as a treatment for mild to moderate Alzheimer's disease is currently recruiting participants across the United States. Trial details are available at ClinicalTrials.gov.
All but six participants in the pilot study were also taking cholinesterase inhibitors, one of the two types of drugs currently approved by the U.S. Food and Drug Administration (FDA) to treat Alzheimer symptoms. No participants were taking memantine (Namenda), the other type of FDA-approved Alzheimer drug.
Atorvastatin and other statins are widely prescribed to reduce high cholesterol levels. Some, but not all, population studies have suggested that taking statins for cholesterol reduction may be associated with a lower risk of developing Alzheimer's disease later in life. Laboratory studies have also shown that the parent molecule of beta-amyloid is found in cholesterol-rich areas of the fatty membranes around nerve cells. Laboratory work has also found that exposing nerve cells to cholesterol appears to increase beta-amyloid production. Beta-amyloid is a protein fragment considered a prime suspect in Alzheimer's disease.
For more information, please see:
- The Alzheimer's Association fact sheet on statins
- An Alzheimer's Association April 4, 2004, research news feature on results of the atorvastatin pilot study reported at a professional meeting prior to publication
- Details about the large federally funded trial of simvastatin (Zocor) at ClinicalTrials.gov