BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
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|ClinicalTrials.gov Identifier: NCT00239746|
Recruitment Status : Unknown
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was: Active, not recruiting
First Posted : October 17, 2005
Last Update Posted : April 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Ibuprofen Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Biomarkers of Nonsteroidal Anti-Inflammatories|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||August 2009|
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
- Changes in biomarker assays [ Time Frame: baseline and 6-12 weeks later ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239746
|United States, Oregon|
|Layton Aging & Alzheimer's Disease Center|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||John Breitner, MD||University of Washington|