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Cerebral and Peripheral Perfusion Pilot Study (CAPP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751907
First Posted: September 12, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by:
University of Wisconsin, Madison
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: atorvastatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Perfusion in the posterior cingulate [ Time Frame: baseline and 4 months ]

Secondary Outcome Measures:
  • Endothelial function and pulse wave velocity [ Time Frame: Baseline and 4 months ]

Enrollment: 16
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: atorvastatin
40mg daily for 4 months
Other Name: Lipitor
Placebo Comparator: 2 Drug: Placebo
Matching placebo daily for 4 months

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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (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
  Contacts and Locations
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
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Principal Investigator: Cynthia M. Carlsson, MD, MS University of Wisconsin, Madison
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia M. Carlsson, MD, MS, University of Wisconsin School of Medicine and Public Health
ClinicalTrials.gov Identifier: NCT00751907     History of Changes
Other Study ID Numbers: IA0138
1R01AG031790 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2008
First Posted: September 12, 2008
Last Update Posted: October 12, 2017
Last Verified: September 2010

Keywords provided by University of Wisconsin, Madison:
Cerebral blood flow

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors