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Find more clinical trials

Effects of Simvastatin on Biomarkers

Start: June 2010
End: October 2015
Enrollment: 120

What Is This Study About?

This trial will test simvastatin, a drug approved to treat high cholesterol and reduce the risk of coronary artery disease, to see if it produces beneficial changes in Alzheimer's-related proteins in the cerebrospinal fluid of cognitively healthy, middle-aged adults.

Do I Qualify To Participate in This Study?

Minimum Age: 45 Years

Maximum Age: 64 Years

Must have:

  • Cognitively normal with no evidence of memory or other cognitive impairments (MMSE > 26, Logical Memory delayed recall > 6, CDR score = 0)
  • Normal or only mildly elevated cholesterol that does not require drug therapy
  • Low-density lipoprotein (LDL) level above 70mg/dL
  • Hamilton Depression Scale (HAM-D) score < 12
  • Body Mass Index between 18 and 34 (exceptions possible)
  • Good recent general health (no trauma or infection in the 4 weeks before lumbar puncture)
  • On stable dose of allowable medications for at least 4 weeks preceding lumbar puncture
  • Platelet count > 100,000

Must NOT have:

  • Pregnancy
  • Any contraindications to lumbar puncture, such as spinal deformity, severe disease or infection in the lumbar puncture region, bleeding tendency, or anticoagulant or blood-thinning medications
  • Taking or has taken a statin medication in the past 12 months
  • Any clinically significant laboratory abnormalities
  • Neurological disorders, including multiple sclerosis, epilepsy, stroke, Parkinson's disease, other degenerative central nervous system disorders, or neuropathy with radicular involvement
  • Acute or chronic major psychiatric disorders, including schizophrenia, affective disorders, or severe anxiety disorders (dysthymia allowed, history of major depression allowed if currently in remission)
  • Unstable or poorly controlled medical problems such as heart failure, diabetes (poorly controlled or insulin dependent), hypertension (blood pressure > 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 nonmelanoma skin cancer), or known HIV-positive status
  • Use of illegal drugs or alcohol abuse (more than 2 drinks per day or 10 drinks per week) within the past year
  • Concurrent participation in another investigational drug study
  • Prohibited medications:
    • Drugs that could interact with statins (itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, cyclosporine, isoniazid, quinidine, or more than 1 quarter per day of grapefruit juice)
    • Medications that act on the central nervous system (antipsychotics, Parkinson's disease medications, anticonvulsants, or central nervous system stimulants)
    • Chronic use of benzodiazepines, sedating antihistamines, or other sedative-hypnotic agents (allowed as long as it is not within 72 hours of lumbar puncture or cognitive testing)
    • Medications affecting coagulation and/or inflammation (coumadin, hydrocortisone, methotrexate or other potent immune-modulating medications, or 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)
  • Family history of dementia: Both parents had/have dementia; on one side of the family, over two consecutive generations or three relatives had/have dementia; one parent with onset of dementia before age 60
  • Major active autoimmune or immunological disorder

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: University of Washington

Collaborator Sponsor

  • Seattle Institute for Biomedical and Clinical Research
  • VA Puget Sound Health Care System

Source: ClinicalTrials.gov ID: NCT01142336

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health