BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

200mg taken orally daily for 6-12 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

200mg matched placebo taken orally daily for 6-12 weeks

Interventions

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Ibuprofen

200mg taken orally daily for 6-12 weeks

Intervention Type DRUG

Placebo

200mg matched placebo taken orally daily for 6-12 weeks

Intervention Type DRUG

Other Intervention Names

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Advil, Motrin

Eligibility Criteria

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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

Minimum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes