Journal
NEUROLOGY
Volume 74, Issue 12, Pages 956-964Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3181d6476a
Keywords
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Categories
Funding
- Pfizer [140015]
- Academy of Healthcare Education
- Alpha Plus
- Astra Zeneca
- Cadmus Medea
- Eisai
- Glia Scientific
- Janssen
- Lundbeck
- Medical Decision Point
- Informed Direct PLC
- MedPlan Communications
- Novartis
- Current Medical Directions
- Memory Fitness Institute
- OCC
- Precept Medical
- Excerpta Medica
- Impact Communication
- Shire
- Embryon
- Fundacion Maria Wolff Alzheimer
- Kenes International
- Prescott Medical
- Six Degrees
- Hc3 Communications
- Insyght
- Ketchum
- Universal CIT
- Center for Health Care Education
- Health LogiX
- American Academy of Neurology
- ONO
- Elan
- Myriad
- Servier
- Sanofi Synthelabo
- Glaxo Smith Kline
- Lilly
- Alzheimer Society of Canada
- Canadian Institutes of Health Research [00725-000, 179009, 74580, 73376]
- Pacific Alzheimer Research Foundation [C06-01]
- NIH [U01AG24904]
- Forest
- Teva
- Wyeth
- NIH, NIDDK [IR21DK062098]
- NIH/NCRR [P20 RR020626]
- Alzheimer's Association
- Academy of Finland [120676, 117 458]
- Resverlogix Pharmaceuticals [0432-0317607]
- AZ Biomedical Research [0008-07]
- Merck Schering-Plough
- Pfizer/Eisai
- Merz
- Medical Research Council [2007-001172-36]
- BRACE (Bristol Research into Alzheimer's and Care of the Elderly)
- Alzheimer's Research Trust [ART/NCG2005/1]
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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 >= 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. Neurology (R) 2010;74:956-964
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