NIH Clinical Research Studies

Protocol Number: 02-M-0305

Active Accrual, Protocols Recruiting New Patients

Title:
The Effect of Short-Term Statin and NSAID Treatment on CSF Beta-amyloid
Number:
02-M-0305
Summary:
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).

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility 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

Special Instructions: Currently Not Provided
Keywords:
Cerebrospinal Fluid
Cholesterol
Statin
NSAID
Antiinflammatory
Dementia
Alzheimer's Disease
Nonsteroidal Antiinflammatory
Recruitment Keywords:
Healthy Volunteer
Conditions:
Alzheimer Disease
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
St George-Hyslop PH. Molecular genetics of Alzheimer's disease. Biol Psychiatry. 2000 Feb 1;47(3):183-99. Review. PMID: 10682216

Small GW, Rabins PV, Barry PP, Buckholtz NS, DeKosky ST, Ferris SH, Finkel SI, Gwyther LP, Khachaturian ZS, Lebowitz BD, McRae TD, Morris JC, Oakley F, Schneider LS, Streim JE, Sunderland T, Teri LA, Tune LE. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society.

JAMA. 1997 Oct 22-29;278(16):1363-71. Review. PMID: 9343469

Bass MP, Yamaoka LH, Scott WK, Gaskell PC, Welsh-Bohmer KA, Roses AD, Saunders AM, Haines JL, Pericak-Vance MA. No association of alpha1-antichymotrypsin flanking region polymorphism and Alzheimer disease risk in early- and late-onset Alzheimer disease patients. Neurosci Lett. 1998 Jul 3;250(2):79-82. PMID: 9697923

Active Accrual, Protocols Recruiting New Patients

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