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 : Active, not recruiting
First Posted : July 15, 2009
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Simvastatin Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2017|
U.S. FDA Resources
40 mg. Simvastatin/day
40 mg Simvastatin/day
Placebo Comparator: Placebo
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Cynthia M. Carlsson, MD, MS||UW Madison School of Medicine and Public Health|