The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Lovostatin Drug: Ibuprofen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | The Effect of Short-Term Statin and NSAID Treatment on CSF Beta-Amyloid |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
- 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
EXCLUSION CRITERIA:
- 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.
- Peptic ulcer disease by history
- Autoimmune disease by history
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00046358 History of Changes |
| Other Study ID Numbers: | 020305, 02-M-0305 |
| Study First Received: | September 26, 2002 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Cerebrospinal Fluid Cholesterol Statin NSAID Antiinflammatory |
Dementia Alzheimer's Disease Nonsteroidal Antiinflammatory Healthy Volunteer |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anti-Inflammatory Agents Ibuprofen Anti-Inflammatory Agents, Non-Steroidal |
Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013