BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Biomarkers of Nonsteroidal Anti-Inflammatories|
- Changes in biomarker assays [ Time Frame: baseline and 6-12 weeks later ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
200mg taken orally daily for 6-12 weeks
Other Name: Advil, Motrin
|Placebo Comparator: 2||
200mg matched placebo taken orally daily for 6-12 weeks
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.
|United States, Oregon|
|Layton Aging & Alzheimer's Disease Center|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||John Breitner, MD||University of Washington|