BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00239746
First received: October 13, 2005
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Ibuprofen
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biomarkers of Nonsteroidal Anti-Inflammatories

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in biomarker assays [ Time Frame: baseline and 6-12 weeks later ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   59 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239746

Locations
United States, Oregon
Layton Aging & Alzheimer's Disease Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
Principal Investigator: John Breitner, MD University of Washington
  More Information

Publications:
Responsible Party: John C.S. Breitner, MD MPH, University of Washington/VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT00239746     History of Changes
Other Study ID Numbers: IA0086, R01AG024010
Study First Received: October 13, 2005
Last Updated: April 28, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Nonsteroidal Anti-inflammatories
NSAIDS

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014