BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

April 28, 2009 updated by: National Institute on Aging (NIA)

Biomarkers of Nonsteroidal Anti-Inflammatories

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Layton Aging & Alzheimer's Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

59 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Ibuprofen
200mg taken orally daily for 6-12 weeks
Other Names:
  • Advil, Motrin
Placebo Comparator: 2
Drug: Placebo
200mg matched placebo taken orally daily for 6-12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in biomarker assays
Time Frame: baseline and 6-12 weeks later
baseline and 6-12 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: John Breitner, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0086
  • R01AG024010 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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