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?
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
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?
Collaborator Sponsor
-
Seattle Institute for Biomedical and Clinical Research
-
VA Puget Sound Health Care System
Source:
ClinicalTrials.gov ID:
NCT01142336