BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00239746

Run by

National Institute on Aging (NIA)

People needed

40

Starts

2005-10-01

Expected to finish

2009-08-01

Last updated by the study team

2009-04-29

Who can join

Age: 59 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Layton Aging & Alzheimer's Disease Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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