期刊
NEUROLOGY
卷 77, 期 6, 页码 556-563出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318228bf11
关键词
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资金
- NIH (NIA/NCRR)
- Baxter International Inc.
- Wyeth
- Pfizer Inc
- Janssen Alzheimer Immunotherapy Research & Development, LLC
- NIH/NIA
- Eli Lilly and Company
- Avid Radiopharmaceuticals, Inc.
- Novartis
- Elan Corporation
- Bristol-Myers Squibb
- Alzheimer Association
- US Department of Defense
- Medivation, Inc.
- Bayer Schering Pharma
- Abbott
- GlaxoSmithKline
- Myriad Genetics, Inc.
- Neurochem Inc
- Sanofi-Synthelabo Research
- Janssen
- Eisai Inc.
- Merck Serono
- Mitsubishi Tanabe Pharma Corporation
- NIH (NIA, NIMH)
- Alzheimer's Association
- American Health Assistance Foundation
- National Alliance for Research on Schizophrenia and Affective Disorders (NARSAD)
- Shire plc
- NIH (NIA, NINDS)
- Kavli Neuroscience Institute at Yale
- Merck
- NIA [U01AG10483]
- Forest Laboratories, Inc.
Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. Neurology (R) 2011;77:556-563
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