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Cerebral and Peripheral Perfusion Pilot Study (CAPP)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00751907
First received: September 10, 2008
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Perfusion in the posterior cingulate [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function and pulse wave velocity [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Medicine and Public Health
  More Information

Additional Information:
The Wisconsin Comprehensive Memory Program (WCMP)  This link exits the ClinicalTrials.gov site

Publications:

Additional 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
Study First Received: September 10, 2008
Last Updated: September 27, 2010
Health Authority: United States: Institutional Review Board

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013