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Evaluating Simvastatin's Potential Role in Therapy (ESPRIT)

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), June 2007

Sponsors and Collaborators: National Institute on Aging (NIA)
Paul Beeson Faculty Scholars Program
The John A. Hartford Foundation
The Atlantic Philanthropies
Starr Foundation
American Federation for Aging Research
Merck
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00486044
  Purpose

The purpose of this study is to see how simvastatin, a cholesterol lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid 42 found in the fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) the brain's handling of cholesterol.


Condition Intervention Phase
Alzheimer Disease
Drug: Simvastatin
Phase II

Genetics Home Reference related topics:   Alzheimer disease  

MedlinePlus related topics:   Alzheimer's Disease   Cholesterol  

ChemIDplus related topics:   Simvastatin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Effect of Statins on Pathobiology of Alzheimer's Disease

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

Primary Outcome Measures:
  • Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in biomarkers of CNS cholesterol metabolism, inflammatory markers, and cerebral perfusion [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Changes in cognitive function [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   February 2005
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects substances in the body called beta-amyloid 40 and beta-amyloid 42, as well as blood flow to the brain. These substances are found in both the brain and the fluid around the brain and spinal cord. High amounts of these substances may be associated with a greater risk of getting Alzheimer's disease.

The ESPRIT study will include 100 middle-aged adults (35-69 yrs) who have a parent with documented Alzheimer's disease. This study will see how the use of a particular statin medication, simvastatin, affects spinal fluid levels of beta-amyloid, inflammation, and cholesterol. In addition, these changes will be compared to changes in memory and thinking skills monitored throughout the study. Fifty of the ESPRIT subjects will also participate in the MRI substudy, which is examining the effects of the study medication on blood flow to structures in the brain that are associated with Alzheimer's disease.

Participants will take part in 5 visits (and an additional 2 visits, if participating in the MRI substudy) over the course of 9 months. Participants will undergo fasting blood tests (baseline, month 3, and month 9 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits), undergo lumbar puncture procedure (baseline and month 9 visits), complete memory testing (baseline, month 3 and month 9 visits), and MRI procedure (baseline and month 9 visits), if participating in MRI substudy. Participants will be randomly assigned to receive either simvastatin or a placebo each night for 9 months.

  Eligibility
Ages Eligible for Study:   35 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Age 35 to 69
  • Parent with Alzheimer's disease

Exclusion Criteria:

  • Current use of cholesterol lowering medication
  • History of liver disease
  • History of adverse reaction to statin medications
  • History of previous lumbar spine surgery
  • Elevated lab values (creatine kinase and creatinine)
  • Use of prohibited medications: Simvastatin, Pravastatin, Cholestyramine, Lovastatin, Colestipol, Gemfibrozil, Niacin, Atorvastatin, Fluvastatin, Fenofibrate, Rosuvastatin, Clarithromycin, Cyclosporine, Digoxin, Erythromycin, Itraconazole, Ketaconazole, Fluconazole, Nefazodone, Warfarin, Saquinavir, Ritonavir, Indinavir, Nelfinavir, Amprenavir, Amiodarone, Verapamil
  • History of dementia
  • Currently pregnant
  • Use of large quantities of grapefruit juice (more than 1 quart per day)
  • Current involvement in another investigational drug study
  • Contraindications to MRI
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486044

Contacts
Contact: Hanna Blazel, MS     608-256-1901 ext 11692     hmb@medicine.wisc.edu    
Contact: Tami Markgraf, BA     608-256-1901 ext 12923     tsm@medicine.wisc.edu    

Locations
United States, Wisconsin
University of Wisconsin     Recruiting
      Madison, Wisconsin, United States, 53705

Sponsors and Collaborators
National Institute on Aging (NIA)
Paul Beeson Faculty Scholars Program
The John A. Hartford Foundation
The Atlantic Philanthropies
Starr Foundation
American Federation for Aging Research
Merck

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

Wisconsin Comprehensive Memory Program  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   IA0116, 1K23AG026752-01
First Received:   June 12, 2007
Last Updated:   May 29, 2008
ClinicalTrials.gov Identifier:   NCT00486044
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
amyloid protein  
apolipoprotein  
central nervous system  
disease /disorder proneness /risk  
inflammation  

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

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

ClinicalTrials.gov processed this record on July 03, 2008




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