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BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239746
Recruitment Status : Unknown
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2005
Last Update Posted : April 29, 2009
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Ibuprofen Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biomarkers of Nonsteroidal Anti-Inflammatories
Study Start Date : October 2005
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: 1 Drug: Ibuprofen
200mg taken orally daily for 6-12 weeks
Other Name: Advil, Motrin

Placebo Comparator: 2 Drug: Placebo
200mg matched placebo taken orally daily for 6-12 weeks

Primary Outcome Measures :
  1. Changes in biomarker assays [ Time Frame: baseline and 6-12 weeks later ]

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239746

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United States, Oregon
Layton Aging & Alzheimer's Disease Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: John Breitner, MD University of Washington
Additional Information:
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Responsible Party: John C.S. Breitner, MD MPH, University of Washington/VA Puget Sound Health Care System Identifier: NCT00239746    
Other Study ID Numbers: IA0086
R01AG024010 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Keywords provided by National Institute on Aging (NIA):
Nonsteroidal Anti-inflammatories
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action