BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories - Full Text View

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

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
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:	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

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

National Institute on Aging (NIA)

Investigators

Principal Investigator:

John Breitner, MD

University of Washington

More Information

Additional Information:

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

Publications:

Weggen S, Eriksen JL, Das P, Sagi SA, Wang R, Pietrzik CU, Findlay KA, Smith TE, Murphy MP, Bulter T, Kang DE, Marquez-Sterling N, Golde TE, Koo EH. A subset of NSAIDs lower amyloidogenic Abeta42 independently of cyclooxygenase activity. Nature. 2001 Nov 8;414(6860):212-6.

McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci U S A. 1999 Jan 5;96(1):272-7. Erratum in: Proc Natl Acad Sci U S A 1999 May 11;96(10):5890.

Montine TJ, Sidell KR, Crews BC, Markesbery WR, Marnett LJ, Roberts LJ 2nd, Morrow JD. Elevated CSF prostaglandin E2 levels in patients with probable AD. Neurology. 1999 Oct 22;53(7):1495-8.

Zandi PP, Anthony JC, Hayden KM, Mehta K, Mayer L, Breitner JC; Cache County Study Investigators. Reduced incidence of AD with NSAID but not H2 receptor antagonists: the Cache County Study. Neurology. 2002 Sep 24;59(6):880-6.

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

Anti-Inflammatory Agents
Ibuprofen
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases

Anti-Inflammatory Agents, Non-Steroidal
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Nervous System Diseases
Alzheimer Disease

Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009