Phase 2
Completed N=100
Evaluating Simvastatin's Potential Role in Therapy
Source: ClinicalTrials.gov NCT00486044 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42 — -5.2; -3.1 ng/L — p=0.966
Summary
The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42 |
-5.2; -3.1 | 0.966 |
| SECONDARY Changes in Regional Cerebral Blood Flow on MRI |
4.09; -5.08 | 0.015 sig |
| SECONDARY Change in Inflammatory Markers |
-1.16; -0.31 | 0.113 |
| SECONDARY Changes in Cognitive Performance |
0.40; 0.26 | 0.210 |
Eligibility Criteria
Inclusion Criteria
- Age 35 to 69
- Parent with Alzheimer's disease
Exclusion Criteria
- Current use of cholesterol-lowering medication
- Active liver disease
- History of adverse reaction to statins
- Contraindication to lumbar puncture
- Elevated lab values (creatine kinase and creatinine)
- Use of medications known to interact with statins
- History of dementia
- Currently pregnant or planning to become pregnant
- Use of large quantities of grapefruit juice (more than 1 quart per day)
- Current involvement in another investigational drug study
- Contraindications to MRI (for MRI sub-study)
- Ethical contraindication to placebo (persons with high vascular risk)
Data sourced from ClinicalTrials.gov (NCT00486044). 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. Informational only — not medical advice.