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Home > "T" Clinical Trials Conditions > 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 Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated with Alzheimer's Disease
The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated with Alzheimer's Disease
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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).
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020305; 02-M-0305
Study Start Date: September 18, 2002
Record last reviewed: September 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046358
Other Alzheimer Disease Studies:
1. Study of Melatonin: Sleep Problems in Alzheimer's Disease
2. Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study
3. A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study).
4. Evaluation Of Three Doses of NS 2330 in Patients with Mild to Moderate Dementia of the Alzheimer’s Type
5. Memory Impairment Study (Mild Cognitive Impairment Study)
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated with Alzheimer's Disease
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