NCT00239746

BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Biomarkers of Nonsteroidal Anti-Inflammatories

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the effect of ibuprofen on the levels of a number of different proteins (called biomarkers) in cerebrospinal fluid (CSF), blood, and urine to see whether ibuprofen can influence certain biomarkers associated with the progression of Alzheimer's Disease.

Detailed description

The hypothesis to be tested is that the possible role of ibuprofen in preventing AD can be detected in changes in biomarkers of AD. Eligible participants will complete an enrollment visit to include: a physical exam, a neurological exam, neuropsychological testing, and a minor blood draw. At the second visit, approximately 2 weeks later, participants will undergo a baseline lumbar puncture, and will be issued either ibuprofen or placebo to take once daily for 6-12 weeks. Both the participants and the clinicians will be masked to treatment assignment. After 6-12 weeks, the participants will undergo a second, and final, lumbar puncture. This will complete participant involvement in the study.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Ibuprofen	200mg taken orally daily for 6-12 weeks
DRUG	Placebo	200mg matched placebo taken orally daily for 6-12 weeks

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2005-10-17
• Last updated: 2009-04-29

Locations

1 site across 1 country: United States