The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease

NCT00046358 | Completed Phase 4

• 2 other identifiers: 02030502-M-0305
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer Disease

Keywords

Cerebrospinal Fluid; Cholesterol; Statin; NSAID; Antiinflammatory; Dementia; Alzheimer's Disease; Nonsteroidal Antiinflammatory; Healthy Volunteer

Interventions

Lovostatin DRUG

Ibuprofen DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• St George-Hyslop PH. Molecular genetics of Alzheimer's disease. Biol Psychiatry. 2000 Feb 1;47(3):183-99. doi: 10.1016/s0006-3223(99)00301-7.

  PMID: 10682216 BACKGROUND

• 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.

  PMID: 9343469 BACKGROUND

• 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. doi: 10.1016/s0304-3940(98)00398-x.

  PMID: 9697923 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 26, 2002
• First Posted: September 27, 2002
• Study Start: September 1, 2002
• Study Completion: August 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-08

Locations

US (1)