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| Sponsored by: |
National Institute on Aging (NIA) |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00239746 |
Purpose
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.
| Condition | Intervention | Phase |
|
Alzheimer's Disease |
Drug: Ibuprofen Drug: Placebo |
Phase I |
| Genetics Home Reference related topics: | Alzheimer disease |
| MedlinePlus related topics: | Alzheimer's Disease |
| ChemIDplus related topics: | Ibuprofen Dexibuprofen |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Biomarkers of Nonsteroidal Anti-Inflammatories |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Ibuprofen
200mg taken orally daily for 6-12 weeks
|
| 2: Placebo Comparator |
Drug: Placebo
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.
Eligibility
| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susanne Crane | 503-494-9399 | cranes@ohsu.edu |
| United States, Oregon | |||||
| Layton Aging & Alzheimer's Disease Center | Recruiting | ||||
| Portland, Oregon, United States, 97239 | |||||
| Contact: Susanne Crane, BS 503-494-9399 cranes@ohsu.edu | |||||
| Contact: Jane Anau 206-277-4723 anauj@u.washington.edu | |||||
| Sub-Investigator: Joseph Quinn, MD | |||||
| Principal Investigator: | John Breitner, MD | University of Washington |
More Information
Layton Aging & Alzheimer's Disease Center 
  |
| Responsible Party: | University of Washington/VA Puget Sound Health Care System ( John C.S. Breitner, MD MPH ) |
| Study ID Numbers: | IA0086, R01AG024010 |
| First Received: | October 13, 2005 |
| Last Updated: | May 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00239746 |
| Health Authority: | United States: Federal Government |
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