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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
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: atorvastatin Drug: Placebo Phase 2

Detailed Description:

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.

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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
Experimental: Atorvastatin
40mg Atorvastatin nightly for 4 months
Drug: atorvastatin
40mg daily for 4 months
Other Name: Lipitor

Placebo Comparator: Placebo
matching placebo nightly for 4 months
Drug: Placebo
Matching placebo daily for 4 months




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Endothelial function [ Time Frame: Baseline and 4 months ]
    Brachial artery reactivity was used to measure endothelial function



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
Karen Lazar
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Cynthia M. Carlsson, MD, MS University of Wisconsin, Madison
Additional Information:
Publications of Results:
Other Publications:
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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
Keywords provided by University of Wisconsin, Madison:
Cerebral blood flow
Additional relevant MeSH terms:
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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