Alzheimer's DiseasePhase 1NCT00239746
BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories
A Phase 1 study testing Ibuprofen in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 59 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 59 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Layton Aging & Alzheimer's Disease Center
Portland, Oregon, 97239
About this study
Official title: Biomarkers of Nonsteroidal Anti-Inflammatories
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Ibuprofen, Placebo
- Keywords
- Nonsteroidal Anti-inflammatories, NSAIDS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil, Motrin
200mg taken orally daily for 6-12 weeks
PlaceboDrug
200mg matched placebo taken orally daily for 6-12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ibuprofen |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in biomarker assays
Measured: baseline and 6-12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- John Breitner, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239746
- Sponsor's protocol ID
- IA0086
- Other IDs
- R01AG024010
- Status last verified
- Apr 2009
- First submitted
- 13 Oct 2005
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11700559McAdam 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.
PubMed 9874808Montine 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.
PubMed 10534257Zandi 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.
PubMed 12297571
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Nonsteroidal Anti-Inflammatories
- ClinicalTrials.gov ID
- NCT00239746
- Acronym / sponsor ID
- IA0086
- Conditions
- Alzheimer's Disease
- Keywords
- Nonsteroidal Anti-inflammatories, NSAIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ibuprofen |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 59 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Advil, Motrin200mg taken orally daily for 6-12 weeks | Drug | 1 |
| Placebo200mg matched placebo taken orally daily for 6-12 weeks | Drug | 2 |
Primary outcome
Changes in biomarker assays
Time frame: baseline and 6-12 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
- Background: PubMed 11700559Weggen 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.
- Background: PubMed 9874808McAdam 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.
- Background: PubMed 10534257Montine 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.
- Background: PubMed 12297571Zandi 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.
- Layton Aging \& Alzheimer's Disease CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Breitner, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in biomarker assays (time frame: baseline and 6-12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00239746, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.