Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease (SHARP)
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|ClinicalTrials.gov Identifier: NCT00939822|
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|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|
|Actual Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
40 mg. Simvastatin/day
40 mg Simvastatin/day
Placebo Comparator: Placebo
- Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP [ Time Frame: Baseline and 18 months ]
Change in CSF beta-amyloid-42 was defined as the ratio of 18-month levels to baseline levels.
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 (Multi-Analyte Profiling) ) [ Time Frame: Baseline and 18 months ]
Change in CSF beta-amyloid-40 was defined as the ratio of 18-month levels to baseline levels.
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 18 months ]
Changes in CSF sAPP-alpha and sAPP-beta were defined as the ratio of 18-month levels to baseline levels.
sAPP-alpha and sAPP-beta are components of beta-amyloid that provide information on beta-amyloid breakdown.
- Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP [ Time Frame: Baseline and 18 months ]
Changes in CSF t-tau and p-tau were defined as the ratio of 18-month levels to baseline levels.
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.
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|
|Fitchburg, Wisconsin, United States, 53711|
|Principal Investigator:||Cynthia M. Carlsson, MD, MS||UW Madison School of Medicine and Public Health|