NEW ORLEANS -- High-dose atorvastatin in patients with Alzheimer's disease slowed progressive cognitive deterioration and improved depressive symptoms in a first-of-its-kind small, randomized, double-blind trial, D. Larry Sparks, Ph.D., said at the annual scientific sessions of the American Heart Association.
The definitive word on the efficacy of high-dose statin therapy for the cognitive and behavioral manifestations of Alzheimer's dementia must await completion of two ongoing large multicenter clinical trials, but the results of this single-center 1-year pilot study are certainly promising, said Dr. Sparks, senior scientist and head of the Ralph and Muriel Roberts Laboratory for Neurodegenerative Research at the Sun Health Research Institute, Sun City, Ariz.
He reported on 46 patients with mild to moderate Alzheimer's disease who completed 1 year on 80 mg/day of atorvastatin or placebo in addition to whatever cholinesterase inhibitors they were already on at randomization.
Primary outcomes in the study were change in the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), both administered quarterly.
From a mean baseline score of 20 on the ADAS-cog, both the atorvastatin and placebo groups showed deterioration at 3 months. Thereafter, scores in the statin group stabilized, but the placebo group continued to deteriorate by about 1 point per quarter, so that at 1 year the atorvastatin group had a mean 3.5-point superior score on this instrument.
Mean ADCS-CGIC scores declined with time in both groups. However, the rate of decline was consistently steeper in the placebo arm, with the between-group differences missing statistical significance by the barest of margins at both 9 and 12 months, Dr. Sparks continued.