Status:
UNKNOWN
BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
59+ years
Phase:
PHASE1
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...
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:...
Eligibility Criteria
Inclusion
- Age 59 years or older at time of the first visit
- Family history of one or more first-degree relatives with Alzheimer-like dementia
- Fluency in written and spoken English
- Willingness to limit use of Vitamin E (\<600 IU per day), Non-aspirin NSAIDs, Aspirin (\<81mg per day), Histamine H2 receptor antagonists, and Gingko biloba extract for the duration of the study
- Ability and intention to participate in regular study visits
- Provision of informed consent
Exclusion
- History of peptic ulcer disease complicated by perforation, hemorrhage or obstruction
- History of uncomplicated peptic ulcer with symptoms in the 28 days prior to the first visit
- Clinically significant hypertension, anemia, liver disease, or kidney disease
- Hypersensitivity to aspirin or other NSAIDS
- Concurrent use of warfarin, ticlopidine, or any other type of anti-coagulant
- Concurrent use of systemic corticosteroids
- Use of ≥ 4 doses per week of either of the following in the 14 days prior to the first visit: Non-aspirin NSAIDs, Aspirin (\>81mg per day), or Histamine H2 receptor antagonists
- Current plasma creatinine ≥1.5mg/dL
- Enrollment in any trial that is likely to interfere with BONSAI procedures or affect treatment outcomes
- Cognitive impairment or dementia
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00239746
Start Date
October 1 2005
End Date
August 1 2009
Last Update
April 29 2009
Active Locations (1)
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1
Layton Aging & Alzheimer's Disease Center
Portland, Oregon, United States, 97239