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Does atorvastatin improve cognition in patients with mild to moderate Alzheimer's disease (AD)?
640 adults (age 50–90 years) patients with mild to moderate probable AD with a mini-mental state examination (MMSE) score 13–25, and taking donepezil 10 mg daily for ≥3 months before screening. The patients also had low-density lipoprotein cholesterol levels (LDL-C) between 95 and 195 mg/dl.
87 sites in 10 countries (USA, Germany, Canada, UK, Australia, Spain, South Africa, Sweden, Austria and Denmark).
Atorvastatin 80 mg daily or placebo for 72 weeks. Both groups also took donepezil 10 mg daily. After 72 weeks, the participants in the atorvastatin group were randomised to either continue atorvastatin or switch to placebo.
(1) Primary outcomes: cognitive performance (Alzheimer's Disease Assessment Scale – cognitive subscale, ADAS-Cog, 11-item, 70-point scale) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change, ADCS-CGIC). (2) Secondary outcomes: Neuropsychiatric Inventory (NPI), modified ADAS-Cog (13-item, 85-point scale), MMSE, Clinical Dementia Rating sum of boxes (CDR-SB) and Alzheimer's Disease Functional Assessment and Change Scale (ADFACS).
70.6% completed (65.9% in atorvastatin group, 75.2% in placebo group), 95.9% …