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| Descriptive Information Fields | |||||||||
| Brief Title † | Evaluating Simvastatin's Potential Role in Therapy | ||||||||
| Official Title † | Effect of Statins on Pathobiology of Alzheimer's Disease | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Changes in cerebrospinal fluid beta-amyloid levels [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Alzheimer Disease | ||||||||
| Intervention † | Drug: Simvastatin Drug: Placebo |
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| MEDLINE PMIDs | 11296263, 11344276, 15734937 | ||||||||
| Links | Wisconsin Comprehensive Memory Program  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | February 2005 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 69 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00486044 | ||||||||
| Organization ID | IA0116 | ||||||||
| Secondary IDs †† | 1K23AG026752-01 | ||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
| Collaborators †† | Paul Beeson Faculty Scholars Program The John A. Hartford Foundation The Atlantic Philanthropies Starr Foundation American Federation for Aging Research Merck |
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| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | June 12, 2007 | ||||||||
| Last Updated Date | August 6, 2008 | ||||||||
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