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Atorvastatin does not slow cognitive decline in patients with mild to moderate probable Alzheimer's disease who are taking donepezil

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Question

Question

Does atorvastatin improve cognition in patients with mild to moderate Alzheimer's disease (AD)?

Patients

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.

Setting

87 sites in 10 countries (USA, Germany, Canada, UK, Australia, Spain, South Africa, Sweden, Austria and Denmark).

Intervention

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.

Outcomes

(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).

Patient follow-up

70.6% completed (65.9% in atorvastatin group, 75.2% in placebo group), 95.9% included in efficacy analysis.

Methods

Design

Randomised controlled trial.

Allocation

Not …

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