Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)

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.
ClinicalTrials.gov Identifier: NCT00939822
Recruitment Status : Unknown
Verified March 2017 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2009
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Simvastatin Drug: Placebo Phase 2

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 included 88 adults ages 40-72 with parental history of documented Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had fasting blood tests collected, completed a medical history questionnaire and medication side effect review, underwent lumbar puncture procedure, completed memory testing, and had ultrasound and MRI procedures. Participants were randomly assigned to receive either simvastatin or a placebo each night for 18 months.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date : March 2009
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Active
40 mg. Simvastatin/day
 Drug: Simvastatin
40 mg Simvastatin/day
Placebo Comparator: Placebo
Matching Placebo
 Drug: Placebo
Matching Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in cerebrospinal fluid (CSF) beta-amyloid-42 levels as measured by xMAP [ Time Frame: Baseline and month 9 ]
    CSF beta-amyloid-42 is a substance found in the plaques in the brain of people with Alzheimer's disease and can be detected in CSF. There is no defined normal range yet for middle-aged adults.


Secondary Outcome Measures :
  1. Changes in CSF beta-amyloid-40 levels as measured by xMAP [ Time Frame: baseline and month 9 ]
    CSF beta amyloid-40 is a substance found in the brain vessels of individuals with Alzheimer's disease and has more potent cerebrovascular effects on individuals with Alzheimer's disease than any other form of beta amyloid.

  2. Changes in CSF soluble alpha precursor proteins (sAPP-alpha) and soluble beta precursor proteins (sAPP-beta) as measured by Duplex [ Time Frame: baseline and month 9 ]
    sAPP-alpha and sAPP-beta are components of beta-amyloid that provide information on beta-amyloid breakdown.

  3. Changes in cerebrospinal fluid CSF beta-amyloid-42 levels as measured by Triplex [ Time Frame: baseline and month 9 ]
    CSF beta-amyloid-42 is a substance found in the plaques in the brain of people with Alzheimer's disease and can be detected in CSF. There is no defined normal range yet for middle-aged adults.

  4. Changes in CSF total tau (t-tau) and phosphorylated tau (p-tau) as measured by xMAP [ Time Frame: baseline and month 9 ]
    T-tau and p-tau are substances found in the brain that can provide information on nerve cell health in the brain and tangle formation in nerve cells.

  5. Changes in beta-amyloid peptides as measured by surface-enhanced laser desorption ionization - time of flight (SELDI-TOF) [ Time Frame: baseline and month 9 ]
    Beta-amyloid peptides are components of beta-amyloid that provide information on beta-amyloid metabolism.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent diagnosed with Alzheimer's disease
  • Age 40-72

Exclusion Criteria:

  • Active liver disease
  • History of adverse reaction to statins
  • Contraindication to lumbar puncture
  • Elevated creatine kinase and creatinine lab values
  • Use of medications known to interact with statins
  • History of dementia or mild cognitive impairment
  • Currently pregnant or planning to become pregnant
  • Use of large quantities of grapefruit juice (more than 1 quart per day)
  • Contraindications to MRI (for MRI sub-study)
  • Currently on cholesterol-lowering medication or use in past 4 months
  • History of heart attack, heart problems, stroke and/or diabetes
  • Drinking more than a quart of grapefruit juice per day
  • Metal implants, or metal debris in body (MRI)
  • List of medications that interact with simvastatin
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00939822


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Cynthia M. Carlsson, MD, MS UW Madison School of Medicine and Public Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00939822     History of Changes
Other Study ID Numbers: 2015-0038
R01AG031790-01A1 ( U.S. NIH Grant/Contract )
H-2009-0030 ( Other Identifier: Old IRB Number )
H-2008-0275 ( Other Identifier: Old IRB Number )
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

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