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Trial record 1 of 87 for:    Statin Effects on Beta-Amyloid
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Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00939822
First received: July 14, 2009
Last updated: April 8, 2010
Last verified: April 2010
  Purpose

The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.


Condition Intervention
Alzheimer's Disease
Drug: Simvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for AD: "Statins in Healthy, At-Risk Adults: Impact on Amyloid and Regional Perfusion (SHARP)" Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
40 mg. Simvastatin/day
Drug: Simvastatin
40 mg Simvastatin/day
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo

Detailed Description:

Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease.

The SHARP study will include 90 adults ages 45-65 who have a parent with documented Alzheimer's disease. Participants will take part in 9 visits over the course of 18 months. Participants will undergo fasting blood tests, complete a medical history questionnaire, complete medication side effect review through questionnaire, undergo lumbar puncture procedure, complete memory testing, ultrasound and MRI procedure. Participants will be randomly assigned to receive either simvastatin or a placebo each night for 18 months.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent diagnosed with Alzheimer's disease
  • Age 45-65
  • Not taking cholesterol-lowering medications

Exclusion Criteria:

  • Currently on cholesterol-lowering medication or use in past 4 months
  • Previous reaction to statin medications
  • History of heart attack, heart problems, stroke and/or diabetes
  • Pregnancy
  • Drinking more than a quart of grapefruit juice per day
  • History of dementia
  • Metal implants, or metal debris in body (MRI)
  • List of medications that interact with simvastatin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939822

Contacts
Contact: Laura E. Jacobson 608 256-1901 ext 11199 lejacobson@medicine.wisc.edu
Contact: Hanna M. Blazel, MS 608 256-1901 ext 11692 hmb@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Cynthia M. Carlsson, MD, MS         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Cynthia M. Carlsson, MD, MS UW Madison School of Medicine and Public Health
  More Information

Additional Information:
No publications provided

Responsible Party: Cynthia M. Carlsson, MD, MS, UW-Madison School of Medicine and Public Health
ClinicalTrials.gov Identifier: NCT00939822     History of Changes
Other Study ID Numbers: H-2009-0030, RO1-AG031790-01A1
Study First Received: July 14, 2009
Last Updated: April 8, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014