BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Alzheimer's Disease Clinical Trial

Official title:

Biomarkers of Nonsteroidal Anti-Inflammatories

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00239746
• Other study ID #: IA0086
• Secondary ID: R01AG024010
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 13, 2005
• Last updated: April 28, 2009
• Start date: October 2005
• Est. completion date: August 2009

Study information

• Verified date: April 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 59 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Ibuprofen
200mg taken orally daily for 6-12 weeks
• Placebo
200mg matched placebo taken orally daily for 6-12 weeks

Locations

Country	Name	City	State
United States	Layton Aging & Alzheimer's Disease Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Erratum in: Proc Natl Acad Sci U S A 1999 May 11;96(10):5890. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in biomarker assays		baseline and 6-12 weeks later	No