A Phase 2 interventional study of Simvastatin and Placebo in Alzheimer's Disease, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 40 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Prevention
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 88 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 mg. Simvastatin/day
Drug: Simvastatin
Matching Placebo
Drug: Placebo
40 mg Simvastatin/day
Matching Placebo
Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP
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.
Time frame: Baseline and 18 months
Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) )
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.
Time frame: Baseline and 18 months
Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex
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.
Time frame: Baseline and 18 months
Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP
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.
Time frame: Baseline and 18 months
Asymptomatic middle-aged adults (ages 40-72 years) with parental history of AD were recruited from the community through local memory clinics, newsletters, educational talks, booths at health fairs, and newspaper and magazine advertisements.
| Milestone | Simvastatin | Placebo |
|---|---|---|
| Started | 44 | 44 |
| Completed | 42 | 41 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrew from study due to busy schedule | 1 | 1 |
| Withdrew: Mental health issues | 0 | 2 |
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.
| ratio | Simvastatin | Placebo |
|---|---|---|
| Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP | 1.01 (0.96 to 1.07) | 0.98 (0.95 to 1.02) |
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.
| ratio | Simvastatin | Placebo |
|---|---|---|
| Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) ) | 1.03 (0.99 to 1.07) | 0.98 (0.94 to 1.01) |
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.
| ratio | Simvastatin | Placebo |
|---|---|---|
| sAPP-alpha | 0.96 (0.92 to 1.00) | 1.03 (0.97 to 1.09) |
| sAPP-beta | 0.98 (0.93 to 1.02) | 1.00 (0.97 to 1.04) |
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.
| ratio | Simvastatin | Placebo |
|---|---|---|
| Total tau | 1.01 (0.97 to 1.05) | 1.01 (0.98 to 1.05) |
| Phosphorylated tau | 1.16 (0.90 to 1.42) | 1.15 (1.00 to 1.29) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simvastatin | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Placebo | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Categorical(Participants) | Simvastatin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 38 | 79 |
| >=65 years | 3 | 6 | 9 |
| Age, Continuous(years) | Simvastatin | Placebo | Total |
|---|---|---|---|
| Mean | 55.95 ± 6.2 | 54.4 ± 7.8 | 55.21 ± 6.99 |
| Sex: Female, Male(Participants) | Simvastatin | Placebo | Total |
|---|---|---|---|
| Female | 31 | 32 | 63 |
| Male | 13 | 12 | 25 |
| Region of Enrollment(participants) | Simvastatin | Placebo | Total |
|---|---|---|---|
| United States | 44 | 44 | 88 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Wisconsin, Madison