Phase 2
N=88
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00939822 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP — 1.01; 0.98 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP |
1.01; 0.98 | — |
| SECONDARY Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) ) |
1.03; 0.98 | — |
| SECONDARY Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex |
0.96; 1.03; 0.98; 1.00 | — |
| SECONDARY Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP |
1.01; 1.01; 1.16; 1.15 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00939822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.