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Trial record 1 of 1 for:    NCT00046358
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The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00046358
First received: September 26, 2002
Last updated: March 3, 2008
Last verified: August 2005

September 26, 2002
March 3, 2008
September 2002
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Complete list of historical versions of study NCT00046358 on ClinicalTrials.gov Archive Site
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The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease
The Effect of Short-Term Statin and NSAID Treatment on CSF Beta-Amyloid

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).

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.

Interventional
Phase 4
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Lovostatin
  • Drug: Ibuprofen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2005
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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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00046358
020305, 02-M-0305
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National Institute of Mental Health (NIMH)
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National Institutes of Health Clinical Center (CC)
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP