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Atorvastatin Slows Alzheimer's Disease Progression in Pilot Study: Presented at AHA

By Jill Stein

NEW ORLEANS, LA -- November 10, 2004 -- Use of the cholesterol-lowering agent atorvastatin slows the progression of mild Alzheimer's disease, according to a placebo-controlled pilot study.

In a poster presentation at the American Heart Association (AHA) Scientific Sessions 2004, Larry Sparks, PhD, senior scientist and chief of the Roberts Laboratory for Neurodegenerative Disease Research, Sun Health Research Institute, Sun City, Arizona, said that after 1 year of treatment, patients with Alzheimer's disease "had a clear clinical benefit" when compared to patients on placebo.

"The patients had stabilized disease and their cognition did not decline, he said. "At minimum, the drug delays entrance to nursing homes, at best, it improves the quality of patient's life."

Dr. Sparks and colleagues assigned 25 patients to daily atorvastatin 80 mg treatment and 21 to matching placebo. The average age of the patients was 78 and two thirds were men.

The patients were assessed with the Alzheimer's Disease Assessment Scale (ADAS-cog), Mini-Mental State Examination, and the Geriatric Depression Scale (GDS) as well as the Neuropsychiatry Inventory.

He said that initially patients taking atorvastatin were no different than patients taking placebo. At baseline, the treatment arms recorded a score of 7.5 on the Inventory.

Dr. Sparks said that the difference between the treatment arms began to be noticeable after 3 months.

After 12 months of treatment, patients taking atorvastatin scored an average of 9, com pared to 16 in placebo patients. At this time point, all scores improved, and the GDS score showed a significant improvement at the P =.04 level, he said. Overall, 53% of the patients taking atorvastatin stabilized or improved, compared to 28% of patients in the placebo arm.

While elevated cholesterol was not one of the criteria for study entry, patients taking atorvastatin reduced their levels of low-density lipoprotein cholesterol from 124 mg/dL to 57 mg/dL and decreased total cholesterol by 40%.

Atorvastatin does not cross the blood-brain barrier, so the observed improvements must be related to decreases in cholesterol levels in the blood, said Dr. Sparks. He theorized that when the circulating cholesterol level goes down in response to treatment, circulating levels of beta amyloid also decline. The brain then works to restore the blood levels of beta amyloid by sending or "clearing" excess beta amyloid from the brain to the blood. With the amyloid removed from the brain, there is less of the substance available to create plaques in the brain characteristic of progression in Alzheimer's disease, he explained.

While Dr. Sparks was enthusiastic about his results, he says that it is too early to recommend giving atorvastatin or other statins to prevent or treat Alzheimer's disease.


[Presentation title: "Benefits of Atorvastatin in Subjects With Alzheimer's Disease." Abstract 3756]

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