Phase 4
Completed N=49
Effects of Simvastatin on Biomarkers
Source: ClinicalTrials.gov NCT01142336 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year — 5.3; 0.5 1-yr change, pg/ml — p=0.53
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year |
5.3; 0.5 | 0.53 |
| PRIMARY Change From Baseline in CSF Total Tau at 1 Year |
-0.1; 1.6 | 0.36 |
| PRIMARY Change From Baseline in CSF ptau181 at 1 Year |
-2.9; 1.7 | 0.25 |
Eligibility Criteria
Inclusion Criteria (participants must meet the following criteria)
- If female of childbearing potential, must have negative pregnancy test at baseline, and all subsequent visits.
- Age 45 to 64 years inclusive.
- Considered cognitively normal with no evidence of memory or other cognitive impairments (MMSE >26, Logical Memory delayed recall > 6, CDR score of 0).
- Normal or only mildly elevated cholesterol which does not require drug therapy based on National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP-III) guidelines.
- An LDL level above 70mg/dL.
- Hamilton Depression Scale (HAM-D) score 100,000.
Exclusion Criteria (participants must NOT satisfy any of the following conditions)
- Any contraindications to LP, such as spinal deformity, severe disease or infection in the LP region, bleeding tendency, anticoagulant or blood-thinning medications.
- Taken a statin medication in the past 12 months.
- Any clinically significant laboratory abnormalities.
- Any neurological disorders: multiple sclerosis, epilepsy, stroke, Parkinson's, other degenerative CNS disorders, or neuropathy with radicular involvement.
- Acute or chronic major psychiatric disorders: schizophrenia, affective disorders, or severe anxiety disorders. (Dysthymia allowed, history of MDD allowed if currently in remission)
- Unstable or poorly controlled medical problems such as: heart failure, diabetes (poorly controlled or insulin dependent), hypertension (BP >160/100), pulmonary disease with hypoxia or hypercapnia, significant liver disease or known hepatitis C seropositivity, renal failure, treatment for cancer in the past 2 years (other than non-melanoma skin cancer) or known HIV positive status.
- Use of illegal drugs or alcohol abuse (>2 drinks/day or 10/week) within the past year.
- Concurrent participation in another investigational drug study.
- Use of any exclusionary medications in the 4 weeks prior to screening:
- Drugs which could interact with statins: itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, cyclosporine, isoniazid, quinidine, or large quantities of grapefruit juice (>1 quart daily)
- Central nervous system acting medications: antipsychotics, anti-Parkinson's disease medications, anti convulsants, or CNS stimulants
- Chronic use of benzodiazepines, sedating antihistamines, or other sedative-hypnotic agents (prn use is allowed as long as it is not within 72 hours of LP or cognitive testing)
- Medications affecting coagulation and/or inflammation: coumadin, potent anti-inflammatory medications (hydrocortisone, methotrexate or other potent immune-modulating medications), and anti-HIV medications (Aspirin up to 325 mg/day is allowed.)
- Lipid-lowering drugs: fibrates or niacin >500mg/day (stable dose of omega-3 is allowed)
- Does the subject's family history meet any of the following criteria?
- Both parents had/have dementia
- On one side of the family, over two consecutive generations three relatives had/have dementia?
- One parent had an onset of dementia before age 60?
- Does the subject have a major active autoimmune or immunological disorder?
Data sourced from ClinicalTrials.gov (NCT01142336). 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.