TUESDAY, Nov. 9, 2004 (HealthDayNews) -- A widely used cholesterol-lowering drug improved memory and cognition as well as depressive symptoms in people with mild to moderate Alzheimer's disease, according to results of a small study.
"This is the first investigational use in 10 years of an FDA-approved drug that shows promise in Alzheimer's," said study author Larry Sparks, head of the Roberts Laboratory for Neurodegenerative Disease Research at Sun Health Research Institute in Sun City, Ariz. "We did find significant changes in a small group of patients."
The results of this pilot study, which involved the drug Lipitor (generic name atorvastatin), were presented Tuesday at a the American Heart Association's scientific sessions in New Orleans.
"It is preliminary because it is so small," said William Thies, vice president for medical and scientific affairs at the Alzheimer's Association. "It's encouraging, but it has got a lot of difficulties with it."
The trial does represent a step forward in statin research, Thies added. "We have a lot of epidemiological data that's all strengthened because it all tends to point in the same direction. But now we're beginning to move on to the next logical step -- which is to collect some of the trial data, where we're really seeing if we can intervene and change variables," he said.
In earlier studies, rabbits that were given cholesterol developed features of Alzheimer's. Removing cholesterol either through the diet or with cholesterol-lowering drugs reversed the Alzheimer's path in animals, Sparks said.
Researchers have also shown excessive levels of cholesterol in the brains of Alzheimer's patients.
This particular study randomly assigned 46 patients to receive either 80 milligrams of Lipitor (which was provided by the maker, Pfizer Inc.) or a placebo for one year in addition to cholinesterase inhibitors, which are the only drugs approved to treat Alzheimer's. The participants, who were all ambulatory and were an average of 78 years old, were assessed quarterly for one year.
During the first three months, the participants deteriorated in both memory and cognition. At six months, however, there was an improvement and, at one year, 53 percent of the Lipitor group had improved or stabilized vs. 28 percent of those in the placebo group. There was also a significant improvement in depressive symptoms at the end of the year.
"Bad" cholesterol levels dropped by more than 50 percent, while total cholesterol dropped by more than 40 percent.
"At a minimum, it delayed their entrance into nursing homes," Sparks said. "We have extended these individuals' quality of life by 18 months. One individual who was on Lipitor would have become bedridden during the time of the study, but he is still dancing."
Sparks said he chose Lipitor because it had the biggest effect of all the statins on cholesterol. The drug also does not cross the blood-brain barrier, and Sparks specifically wanted to see the impact of lowering blood cholesterol on Alzheimer's. The six-month lag in seeing any benefit can be explained by the fact that changes in the blood needed time to translate into changes in the brain.
Pfizer and the National Institute on Aging are both conducting much larger trials, with results likely to be available in about two years, Thies said.
Neither Sparks nor Thies were ready to recommend statins for Alzheimer's patients, but those who are on them already for their cholesterol just may have an added benefit.
"The statin drugs have a really good history of treating people with minimum side effects, and if there's any indication that you ought to be on a statin you're silly if you're not," Thies said.
The Alzheimer's Association has a fact sheet on statins.