Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 72 |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | September 2017 |
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.
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 included 88 adults ages 40-72 with parental history of documented
Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had
fasting blood tests collected, completed a medical history questionnaire and medication side
effect review, underwent lumbar puncture procedure, completed memory testing, and had
ultrasound and MRI procedures. Participants were randomly assigned to receive either
simvastatin or a placebo each night for 18 months.
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 included 88 adults ages 40-72 with parental history of documented
Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had
fasting blood tests collected, completed a medical history questionnaire and medication side
effect review, underwent lumbar puncture procedure, completed memory testing, and had
ultrasound and MRI procedures. Participants were randomly assigned to receive either
simvastatin or a placebo each night for 18 months.
Inclusion Criteria:
- Parent diagnosed with Alzheimer's disease
- Age 40-72
Exclusion Criteria:
- Active liver disease
- History of adverse reaction to statins
- Contraindication to lumbar puncture
- Elevated creatine kinase and creatinine lab values
- Use of medications known to interact with statins
- History of dementia or mild cognitive impairment
- Currently pregnant or planning to become pregnant
- Use of large quantities of grapefruit juice (more than 1 quart per day)
- Contraindications to MRI (for MRI sub-study)
- Currently on cholesterol-lowering medication or use in past 4 months
- History of heart attack, heart problems, stroke and/or diabetes
- Drinking more than a quart of grapefruit juice per day
- Metal implants, or metal debris in body (MRI)
- List of medications that interact with simvastatin
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