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Cerebral and Peripheral Perfusion Pilot Study (CAPP)

This study has been completed.

Sponsored by: Wisconsin Comprehensive Memory Program
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00751907
  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 II

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease   

ChemIDplus related topics:   Atorvastatin    Atorvastatin calcium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:   Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function

Further study details as provided by National Institute on Aging (NIA):

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
1: Experimental Drug: atorvastatin
40mg daily for 4 months
2: Placebo Comparator 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
Wisconsin Comprehensive Memory Program

Investigators
Principal Investigator:     Cynthia M. Carlsson, MD, MS     University of Wisconsin School of Medicine and Public Health    
  More Information


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

Publications:

Responsible Party:   University of Wisconsin School of Medicine and Public Health ( Cynthia M. Carlsson, MD, MS )
Study ID Numbers:   IA0138
First Received:   September 10, 2008
Last Updated:   September 10, 2008
ClinicalTrials.gov Identifier:   NCT00751907
Health Authority:   United States: Institutional Review Board

Keywords provided by National Institute on Aging (NIA):
Cerebral blood flow  

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Atorvastatin
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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