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Trial record 1 of 1 for:    Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer’s Disease
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Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00939822
First received: July 14, 2009
Last updated: April 8, 2010
Last verified: April 2010

July 14, 2009
April 8, 2010
March 2009
February 2012   (final data collection date for primary outcome measure)
Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Beta-amyloid [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for AD: "Statins in Healthy, At-Risk Adults: Impact on Amyloid and Regional Perfusion (SHARP)" Study

The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.

Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease.

The SHARP study will include 90 adults ages 45-65 who have a parent with documented Alzheimer's disease. Participants will take part in 9 visits over the course of 18 months. Participants will undergo fasting blood tests, complete a medical history questionnaire, complete medication side effect review through questionnaire, undergo lumbar puncture procedure, complete memory testing, ultrasound and MRI procedure. Participants will be randomly assigned to receive either simvastatin or a placebo each night for 18 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Alzheimer's Disease
  • Drug: Simvastatin
    40 mg Simvastatin/day
  • Drug: Placebo
    Matching Placebo
  • Experimental: Active
    40 mg. Simvastatin/day
    Intervention: Drug: Simvastatin
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parent diagnosed with Alzheimer's disease
  • Age 45-65
  • Not taking cholesterol-lowering medications

Exclusion Criteria:

  • Currently on cholesterol-lowering medication or use in past 4 months
  • Previous reaction to statin medications
  • History of heart attack, heart problems, stroke and/or diabetes
  • Pregnancy
  • Drinking more than a quart of grapefruit juice per day
  • History of dementia
  • Metal implants, or metal debris in body (MRI)
  • List of medications that interact with simvastatin
Both
45 Years to 65 Years
Yes
Contact: Laura E. Jacobson 608 256-1901 ext 11199 lejacobson@medicine.wisc.edu
Contact: Hanna M. Blazel, MS 608 256-1901 ext 11692 hmb@medicine.wisc.edu
United States
 
NCT00939822
H-2009-0030, RO1-AG031790-01A1
Yes
Cynthia M. Carlsson, MD, MS, UW-Madison School of Medicine and Public Health
University of Wisconsin, Madison
Not Provided
Principal Investigator: Cynthia M. Carlsson, MD, MS UW Madison School of Medicine and Public Health
University of Wisconsin, Madison
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP