Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00939822
First received: July 14, 2009
Last updated: February 26, 2016
Last verified: February 2016
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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 | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Simvastatin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Simvastatin
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Changes in cerebrospinal fluid (CSF) beta-amyloid-42 levels as measured by xMAP [ Time Frame: Baseline and month 9 ] [ Designated as safety issue: No ]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:
- Changes in CSF beta-amyloid-40 levels as measured by xMAP [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]sAPP-alpha and sAPP-beta are components of beta-amyloid that provide information on beta-amyloid breakdown.
- Changes in cerebrospinal fluid CSF beta-amyloid-42 levels as measured by Triplex [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]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.
- Changes in CSF total tau (t-tau) and phosphorylated tau (p-tau) as measured by xMAP [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]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.
- Changes in beta-amyloid peptides as measured by surface-enhanced laser desorption ionization - time of flight (SELDI-TOF) [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]Beta-amyloid peptides are components of beta-amyloid that provide information on beta-amyloid metabolism.
| Enrollment: | 88 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2017 |
| Primary Completion Date: | September 2013 (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 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.
Eligibility| Ages Eligible for Study: | 40 Years to 72 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939822
Locations
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
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:
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00939822 History of Changes |
| Other Study ID Numbers: | 2015-0038 R01AG031790-01A1 H-2009-0030 H-2008-0275 |
| Study First Received: | July 14, 2009 |
| Last Updated: | February 26, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant 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 |
ClinicalTrials.gov processed this record on September 29, 2016