Cerebral and Peripheral Perfusion Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | June 2006 |
| End Date: | April 2007 |
Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function
The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic,
adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will
beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in
the brain, improving cerebral perfusion, increasing brain activity patterns, and improving
blood vessel function.
adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will
beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in
the brain, improving cerebral perfusion, increasing brain activity patterns, and improving
blood vessel function.
Treatment with cholesterol-lowering medications, specifically statins, is associated with up
to a 73% reduction in the prevalence of AD, suggesting a potentially promising role for
statins in the prevention of AD. In order to better understand the mechanisms through which
statins may possibly modify blood AD risk, this study will evaluate whether administration of
atorvastatin favorably alters blood flow in the brain (measured by magnetic resonance imaging
(MRI)) and blood vessel function (measured by ultrasound).
Participants will be asked to attend 3 visits over the course of the 4-month study. At the
initial visit, participants will complete a short questionnaire about their past medical
history and medication history. At the baseline visit, participants will be randomized in a
1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and
follow-up visits, participants will provide an update on medical problems and medications,
review any potential side effects, and have fasting blood tests collected for safety
monitoring, including liver and muscle enzyme monitoring. In addition, all participants will
have MRI and ultrasound measures collected.
to a 73% reduction in the prevalence of AD, suggesting a potentially promising role for
statins in the prevention of AD. In order to better understand the mechanisms through which
statins may possibly modify blood AD risk, this study will evaluate whether administration of
atorvastatin favorably alters blood flow in the brain (measured by magnetic resonance imaging
(MRI)) and blood vessel function (measured by ultrasound).
Participants will be asked to attend 3 visits over the course of the 4-month study. At the
initial visit, participants will complete a short questionnaire about their past medical
history and medication history. At the baseline visit, participants will be randomized in a
1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and
follow-up visits, participants will provide an update on medical problems and medications,
review any potential side effects, and have fasting blood tests collected for safety
monitoring, including liver and muscle enzyme monitoring. In addition, all participants will
have MRI and ultrasound measures collected.
Inclusion Criteria:
- Adult (ages 40-65) children of parent with documented Alzheimer's disease
Exclusion Criteria:
- Current use of cholesterol lowering medication
- History of liver disease
- History of adverse reaction to statin medications
- Elevated lab values (CK and creatinine)
- Use of medications that counteract with atorvastatin
- History of dementia
- Currently pregnant
- Use of large quantities of grapefruit juice (more than 1 quart/day)
- Current involvement in another investigational drug study
- Contraindications to MRI
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