Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)
Recruitment status was Recruiting
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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 |
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00939822
| 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 |
| United States, Wisconsin | |
| University of Wisconsin-Madison | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: Cynthia M. Carlsson, MD, MS | |
| 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:
|
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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015