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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00046358 |
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 IV |
| Study Type: | Interventional |
| Study Design: | 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:
EXCLUSION CRITERIA:
Contacts and Locations
More Information
| Study ID Numbers: | 020305, 02-M-0305 |
| Study First Received: | September 26, 2002 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00046358 History of Changes |
| Health Authority: | United States: Federal Government |
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Cerebrospinal Fluid Cholesterol Statin NSAID Antiinflammatory |
Dementia Alzheimer's Disease Nonsteroidal Antiinflammatory Healthy Volunteer |
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Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Brain Diseases Neurodegenerative Diseases Pharmacologic Actions |
Delirium, Dementia, Amnestic, Cognitive Disorders Sensory System Agents Analgesics, Non-Narcotic Mental Disorders Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Dementia Tauopathies Central Nervous System Agents |