NCT00239746

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

3.8 years

First QC Date

October 13, 2005

Last Update Submit

April 28, 2009

Conditions

Alzheimer's Disease

Keywords

Nonsteroidal Anti-inflammatoriesNSAIDS

Outcome Measures

Primary Outcomes (1)

  • Changes in biomarker assays

    baseline and 6-12 weeks later

Study Arms (2)

1

EXPERIMENTAL
Drug: Ibuprofen

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IbuprofenDRUG

200mg taken orally daily for 6-12 weeks

Also known as: Advil, Motrin
1
PlaceboDRUG

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

2

Eligibility Criteria

Age59 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Layton Aging & Alzheimer's Disease Center

Portland, Oregon, 97239, United States

Location

Related Publications (4)

  • 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. doi: 10.1038/35102591.

    PMID: 11700559BACKGROUND

  • 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. doi: 10.1073/pnas.96.1.272.

    PMID: 9874808BACKGROUND

  • 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. doi: 10.1212/wnl.53.7.1495.

    PMID: 10534257BACKGROUND

  • 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. doi: 10.1212/wnl.59.6.880.

    PMID: 12297571BACKGROUND

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • John Breitner, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

US(1)