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UnknownPhase 1

BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Biomarkers of Nonsteroidal Anti-Inflammatories

Lead sponsor

National Institute on Aging (NIA)

Asset

Ibuprofen

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥59

Primary endpoint

•Changes in biomarker assays

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIA0086

NCT IDNCT00239746

NihR01AG024010

Timeline

Milestones

Study start2005-10 (month precision)

Study first posted2005-10-17estimated

Last update posted2009-04-29estimated

Primary completion2009-08estimated (month precision)

Study completion2009-08estimated (month precision)

Assets

Drug assets

Ibuprofen

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age59 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Changes in biomarker assays

Time frame:baseline and 6-12 weeks later

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.