Trial record 1 of 1 for:
NCT00239746
BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00239746
First received: October 13, 2005
Last updated: April 28, 2009
Last verified: April 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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
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 |
|---|---|
| Experimental: 1 |
Drug: Ibuprofen
200mg taken orally daily for 6-12 weeks
Other Name: Advil, Motrin
|
| Placebo Comparator: 2 |
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 More Information
Additional Information:
Publications:
| Responsible Party: | John C.S. Breitner, MD MPH, University of Washington/VA Puget Sound Health Care System |
| ClinicalTrials.gov Identifier: | NCT00239746 History of Changes |
| Other Study ID Numbers: | IA0086, R01AG024010 |
| Study First Received: | October 13, 2005 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
Nonsteroidal Anti-inflammatories NSAIDS |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anti-Inflammatory Agents Ibuprofen Therapeutic Uses |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013