Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments ibuprofen, placebo
Phase phase 1
Sponsor National Institute on Aging (NIA)
Start date October 2005
End date August 2009
Trial size 40 participants
Trial identifier NCT00239746, IA0086, R01AG024010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ibuprofen Advil, Motrin
200mg taken orally daily for 6-12 weeks
(Placebo Comparator)
placebo
200mg matched placebo taken orally daily for 6-12 weeks

Primary Outcomes

Measure
Changes in biomarker assays
time frame: baseline and 6-12 weeks later

Eligibility Criteria

Male or female participants at least 59 years old.

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

Additional Information

Official title Biomarkers of Nonsteroidal Anti-Inflammatories
Principal investigator John Breitner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by National Institute on Aging (NIA).