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| Descriptive Information Fields | |||||
| Brief Title † | BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories | ||||
| Official Title † | Biomarkers of Nonsteroidal Anti-Inflammatories | ||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Changes in biomarker assays [ Time Frame: baseline and 6-12 weeks later ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Alzheimer's Disease | ||||
| Intervention † | Drug: Ibuprofen Drug: Placebo |
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| MEDLINE PMIDs | 11700559, 9874808, 10534257, 12297571 | ||||
| Links | Layton Aging & Alzheimer's Disease Center ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | October 2005 | ||||
| Completion Date | August 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00239746 | ||||
| Organization ID | IA0086 | ||||
| Secondary IDs †† | R01AG024010 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | October 13, 2005 | ||||
| Last Updated Date | May 13, 2008 | ||||