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Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe
Stockholm University, Faculty of Social Sciences, Aging Research Center (ARC), (together with KI).
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2010 (English)In: Neurology, ISSN 0028-3878, E-ISSN 1526-632X, Vol. 74, no 12, 956-964 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD.

METHODS: This was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and < 195 mg/dL. Patients were randomized to atorvastatin 80 mg/day or placebo for 72 weeks followed by a double-blind, 8-week atorvastatin withdrawal phase. Coprimary endpoints were changes in cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change [ADCS-CGIC]) at 72 weeks.

RESULTS: A total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated.

CONCLUSIONS: In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events. Classification of evidence: This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.

Place, publisher, year, edition, pages
Minneapolis ; New York: Lancet ; Ovid , 2010. Vol. 74, no 12, 956-964 p.
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Medical and Health Sciences
Identifiers
URN: urn:nbn:se:su:diva-84987DOI: 10.1212/WNL.0b013e3181d6476aPubMedID: 20200346OAI: oai:DiVA.org:su-84987DiVA: diva2:585496
Available from: 2013-01-10 Created: 2013-01-04 Last updated: 2017-12-06Bibliographically approved

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