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BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), May 2008

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00239746
  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 I

Genetics Home Reference related topics:   Alzheimer disease  

MedlinePlus related topics:   Alzheimer's Disease  

ChemIDplus related topics:   Ibuprofen   Dexibuprofen  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Biomarkers of Nonsteroidal Anti-Inflammatories

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 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Ibuprofen
200mg taken orally daily for 6-12 weeks
2: Placebo Comparator 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:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Age 60 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

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

Contacts
Contact: Susanne Crane     503-494-9399     cranes@ohsu.edu    

Locations
United States, Oregon
Layton Aging & Alzheimer's Disease Center     Recruiting
      Portland, Oregon, United States, 97239
      Contact: Susanne Crane, BS     503-494-9399     cranes@ohsu.edu    
      Contact: Jane Anau     206-277-4723     anauj@u.washington.edu    
      Sub-Investigator: Joseph Quinn, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     John Breitner, MD     University of Washington    
  More Information

Layton Aging & Alzheimer's Disease Center  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   University of Washington/VA Puget Sound Health Care System ( John C.S. Breitner, MD MPH )
Study ID Numbers:   IA0086, R01AG024010
First Received:   October 13, 2005
Last Updated:   May 13, 2008
ClinicalTrials.gov Identifier:   NCT00239746
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Ibuprofen
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Mental Disorders
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on July 03, 2008




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