BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

• Status: Unknown status
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Anti-Inflammatory Agents; Ibuprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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