The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT00046358
Recruitment Status :
First Posted : September 27, 2002
Last Update Posted : March 4, 2008
National Institute of Mental Health (NIMH)
Information provided by:
National Institutes of Health Clinical Center (CC)
The purpose of this study is to determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk for developing Alzheimer's Disease (AD).
Condition or disease
Drug: LovostatinDrug: Ibuprofen
There is increasing evidence that nonsteroidal and cholesterol lowering medications may be associated with a delay in the onset of Alzheimer's disease (AD). There is separate evidence that beta-amyloid(1-42) is involved in the pathophysiology of AD and levels of beta-amyloid(1-42) in the cerebrospinal fluid (CSF) of AD patients are significantly lower than that found in controls. It has been suggested that these standard medications may have indirect effects that alter the normal course of AD, but there is no data to directly support this contention in humans. Based on previous work, it is our hypothesis that CSF beta-amyloid(1-42) levels may serve as an early biomarker of AD. Any pharmacological induced change in CSF beta-amyloid(1-42) might have profound implications for the eventual onset of illness. Therefore, the purpose of this study is to evaluate the short-term effects of two commonly prescribed nonsteroidal and cholesterol lowering medications, ibuprofen and lovastatin, on the levels of cerebrospinal fluid beta-amyloid(1-42) in a group of normal controls 'at risk' for developing AD.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Normal volunteer over the age of 18
Cognitively within normal limits at baseline evaluation
Previously evaluated in Protocol 95-M-0096
Women of child-bearing potential will be advised not to become pregnant during the treatment period
Known allergies to lovastatin or ibuprofen
Use of regular dosing of NSAID or statin during the previous month
Concurrent use of cyclosporine, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, HIV protease inhibitors or nefazodone because of possible drug interactions with lovastatin.
Women who are currently pregnant
Concurrent use of anticoagulants, aspirin, beta-adrenergic agents, cimetidine, digoxin and oral hypoglycemics because of possible drug interactions with ibuprofen.