View Clinical Trial (Medical Research Study)
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
| City: |
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53705 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00939822 |
| Primary Contact: |
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Principal Investigator
Cynthia M. Carlsson, MD, MS
UW Madison School of Medicine and Public Health
Laura E. Jacobson
Phone: 608 256-1901 ext. 11199
Email: lejacobson@medicine.wisc.edu
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| Backup Contact: |
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Email: hmb@medicine.wisc.edu
Hanna M. Blazel, MS
Phone: 608 256-1901 ext. 11692
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| Location Contact: |
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Madison, Wisconsin 53705
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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