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BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Nonsteroidal Anti-inflammatories, NSAIDS

Eligibility Criteria

59 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Layton Aging & Alzheimer's Disease Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Changes in biomarker assays

Secondary Outcome Measures

Full Information

First Posted
October 13, 2005
Last Updated
April 28, 2009
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00239746
Brief Title
BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
Official Title
Biomarkers of Nonsteroidal Anti-Inflammatories
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Nonsteroidal Anti-inflammatories, NSAIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Advil, Motrin
Intervention Description
200mg taken orally daily for 6-12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
200mg matched placebo taken orally daily for 6-12 weeks
Primary Outcome Measure Information:
Title
Changes in biomarker assays
Time Frame
baseline and 6-12 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Breitner, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Layton Aging & Alzheimer's Disease Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11700559
Citation
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. doi: 10.1038/35102591.
Results Reference
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PubMed Identifier
9874808
Citation
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. doi: 10.1073/pnas.96.1.272. Erratum In: Proc Natl Acad Sci U S A 1999 May 11;96(10):5890.
Results Reference
background
PubMed Identifier
10534257
Citation
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. doi: 10.1212/wnl.53.7.1495.
Results Reference
background
PubMed Identifier
12297571
Citation
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. doi: 10.1212/wnl.59.6.880.
Results Reference
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Links:
URL
http://www.ohsu.edu/research/alzheimers/index.htm
Description
Layton Aging & Alzheimer's Disease Center

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BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

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