Cerebral and Peripheral Perfusion Pilot Study (CAPP)
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ClinicalTrials.gov Identifier: NCT00751907 |
Recruitment Status :
Completed
First Posted : September 12, 2008
Last Update Posted : September 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: atorvastatin Drug: Placebo | Phase 2 |
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 evaluated whether administration of atorvastatin favorably altered blood flow in the brain (measured by magnetic resonance imaging (MRI)) and blood vessel function (measured by ultrasound).
Participants attended 3 visits over the course of the 4-month study. At the initial visit, participants completed a short questionnaire about their past medical history and medication history. At the baseline visit, participants were randomized in a 1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and follow-up visits, participants provided an update on medical problems and medications, reviewed any potential side effects, and had fasting blood tests collected for safety monitoring, including liver and muscle enzyme monitoring. In addition, all participants had MRI and ultrasound measures collected.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
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Experimental: Atorvastatin
40mg Atorvastatin nightly for 4 months
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Drug: atorvastatin
40mg daily for 4 months
Other Name: Lipitor |
Placebo Comparator: Placebo
matching placebo nightly for 4 months
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Drug: Placebo
Matching placebo daily for 4 months |
- Change in regional cerebral blood flow (rCBF) [ Time Frame: Baseline and 4 months ]rCBF , a measure of cerebral perfusion, is the primary outcome. rCBF was measured by arterial spin-labeling magnetic resonance imaging and used to evaluate effects of atorvastatin vs placebo
- Change in Endothelial function [ Time Frame: Baseline and 4 months ]Brachial artery reactivity was used to measure endothelial function

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Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751907
United States, Wisconsin | |
Karen Lazar | |
Madison, Wisconsin, United States, 53705 |
Principal Investigator: | Cynthia M. Carlsson, MD, MS | University of Wisconsin, Madison |
Publications of Results:
Other Publications:
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00751907 |
Other Study ID Numbers: |
IA0138 K23AG026752 ( U.S. NIH Grant/Contract ) Pilot Award ( Other Grant/Funding Number: Wisconsin Comprehensive Memory Program Pilot Award ) |
First Posted: | September 12, 2008 Key Record Dates |
Last Update Posted: | September 9, 2019 |
Last Verified: | September 2019 |
Cerebral blood flow |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |