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	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Lovostatin  Drug: Ibuprofen	Phase IV

Further Study Details: 

Expected Total Enrollment:  50

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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
1. Normal volunteer over the age of 18
2. Cognitively within normal limits at baseline evaluation
3. Previously evaluated in Protocol 95-M-0096
4. Women of child-bearing potential will be advised not to become pregnant during the treatment period
EXCLUSION CRITERIA:
1. Known allergies to lovastatin or ibuprofen
2. Use of regular dosing of NSAID or statin during the previous month
3. Concurrent use of cyclosporine, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, HIV protease inhibitors or nefazodone because of possible drug interactions with lovastatin.
4. Women who are currently pregnant
5. Concurrent use of anticoagulants, aspirin, beta-adrenergic agents, cimetidine, digoxin and oral hypoglycemics because of possible drug interactions with ibuprofen.
6. Peptic ulcer disease by history
7. Autoimmune disease by history

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  020305; 02-M-0305
Record last reviewed:  September 30, 2004
Last Updated:  November 23, 2004
Record first received:  September 26, 2002
ClinicalTrials.gov Identifier:  NCT00046358
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08