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A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.
The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the blood and spinal fluid of people, and whether the form of a gene called APOE that a person has causes different effects. The molecules we are measuring are thought to be important in the development of Alzheimer's disease (AD), and we are testing whether simvastatin can change proteins to a level that is associated with a reduced risk for AD.
Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an investigational drug in this study.
Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the participant will be blinded. Randomization will be stratified by age and gender.
This study is being funded by the National Institute on Aging. We expect about 120 people will take part in this study at the VA Puget Sound Health Care System over the course of a 2 year enrollment period.
This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).
We would also like to ask a person who knows the participant well (such as a spouse, child, sibling, or good friend) some questions about the participant's health, memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of the study.
Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not need or take any medications to control cholesterol.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
VA Puget Sound Health Care System
University of Washington
Published on BioPortfolio: 2014-08-27T03:13:00-0400
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[This corrects the article DOI: 10.3892/etm.2017.5620.].
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