Alzheimer DiseasePhase 4NCT00046358
The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated With Alzheimer's Disease
A Phase 4 study testing Lovostatin and Ibuprofen in people with Alzheimer Disease, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk for developing Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lovostatin and Ibuprofen
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2005
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal volunteer over the age of 18
- Cognitively within normal limits at baseline evaluation
- Previously evaluated in Protocol 95-M-0096
- Women of child-bearing potential will be advised not to become pregnant during the treatment period
Who cannot join
- Known allergies to lovastatin or ibuprofen
- Use of regular dosing of NSAID or statin during the previous month
- Concurrent use of cyclosporine, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, HIV protease inhibitors or nefazodone because of possible drug interactions with lovastatin.
- Women who are currently pregnant
- Concurrent use of anticoagulants, aspirin, beta-adrenergic agents, cimetidine, digoxin and oral hypoglycemics because of possible drug interactions with ibuprofen.
- Peptic ulcer disease by history
- Autoimmune disease by history
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Short-Term Statin and NSAID Treatment on CSF Beta-Amyloid
The purpose of this study is to determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk for developing Alzheimer's Disease (AD).
Read the detailed description
There is increasing evidence that nonsteroidal and cholesterol lowering medications may be associated with a delay in the onset of Alzheimer's disease (AD). There is separate evidence that beta-amyloid(1-42) is involved in the pathophysiology of AD and levels of beta-amyloid(1-42) in the cerebrospinal fluid (CSF) of AD patients are significantly lower than that found in controls. It has been suggested that these standard medications may have indirect effects that alter the normal course of AD, but there is no data to directly support this contention in humans. Based on previous work, it is our hypothesis that CSF beta-amyloid(1-42) levels may serve as an early biomarker of AD. Any pharmacological induced change in CSF beta-amyloid(1-42) might have profound implications for the eventual onset of illness. Therefore, the purpose of this study is to evaluate the short-term effects of two commonly prescribed nonsteroidal and cholesterol lowering medications, ibuprofen and lovastatin, on the levels of cerebrospinal fluid beta-amyloid(1-42) in a group of normal controls 'at risk' for developing AD.
- Conditions
- Alzheimer Disease
- Being tested
- Lovostatin, Ibuprofen
- Keywords
- Cerebrospinal Fluid, Cholesterol, Statin, NSAID, Antiinflammatory, Dementia, Alzheimer's Disease, Nonsteroidal Antiinflammatory, Healthy Volunteer
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovostatinDrug
IbuprofenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2002 (estimated)
- Study startSep 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046358
- Sponsor's protocol ID
- 020305
- Other IDs
- 02-M-0305
- Status last verified
- Aug 2005
- First submitted
- 26 Sep 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
St George-Hyslop PH. Molecular genetics of Alzheimer's disease. Biol Psychiatry. 2000 Feb 1;47(3):183-99. doi: 10.1016/s0006-3223(99)00301-7.
PubMed 10682216Small GW, Rabins PV, Barry PP, Buckholtz NS, DeKosky ST, Ferris SH, Finkel SI, Gwyther LP, Khachaturian ZS, Lebowitz BD, McRae TD, Morris JC, Oakley F, Schneider LS, Streim JE, Sunderland T, Teri LA, Tune LE. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA. 1997 Oct 22-29;278(16):1363-71.
PubMed 9343469Bass MP, Yamaoka LH, Scott WK, Gaskell PC, Welsh-Bohmer KA, Roses AD, Saunders AM, Haines JL, Pericak-Vance MA. No association of alpha1-antichymotrypsin flanking region polymorphism and Alzheimer disease risk in early- and late-onset Alzheimer disease patients. Neurosci Lett. 1998 Jul 3;250(2):79-82. doi: 10.1016/s0304-3940(98)00398-x.
PubMed 9697923
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-Term Statin and NSAID Treatment on CSF Beta-Amyloid
- ClinicalTrials.gov ID
- NCT00046358
- Acronym / sponsor ID
- 020305
- Conditions
- Alzheimer Disease
- Keywords
- Cerebrospinal Fluid, Cholesterol, Statin, NSAID, Antiinflammatory, Dementia, Alzheimer's Disease, Nonsteroidal Antiinflammatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Sep 2002
- Study completion
- Aug 2005
- First posted
- 27 Sep 2002 (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 determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk for developing Alzheimer's Disease (AD).
Detailed description
There is increasing evidence that nonsteroidal and cholesterol lowering medications may be associated with a delay in the onset of Alzheimer's disease (AD). There is separate evidence that beta-amyloid(1-42) is involved in the pathophysiology of AD and levels of beta-amyloid(1-42) in the cerebrospinal fluid (CSF) of AD patients are significantly lower than that found in controls. It has been suggested that these standard medications may have indirect effects that alter the normal course of AD, but there is no data to directly support this contention in humans. Based on previous work, it is our hypothesis that CSF beta-amyloid(1-42) levels may serve as an early biomarker of AD. Any pharmacological induced change in CSF beta-amyloid(1-42) might have profound implications for the eventual onset of illness. Therefore, the purpose of this study is to evaluate the short-term effects of two commonly prescribed nonsteroidal and cholesterol lowering medications, ibuprofen and lovastatin, on the levels of cerebrospinal fluid beta-amyloid(1-42) in a group of normal controls 'at risk' for developing AD.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Normal volunteer over the age of 18
- Cognitively within normal limits at baseline evaluation
- Previously evaluated in Protocol 95-M-0096
- Women of child-bearing potential will be advised not to become pregnant during the treatment period
Key exclusion criteria (7 listed)
- Known allergies to lovastatin or ibuprofen
- Use of regular dosing of NSAID or statin during the previous month
- Concurrent use of cyclosporine, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, HIV protease inhibitors or nefazodone because of possible drug interactions with lovastatin.
- Women who are currently pregnant
- Concurrent use of anticoagulants, aspirin, beta-adrenergic agents, cimetidine, digoxin and oral hypoglycemics because of possible drug interactions with ibuprofen.
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 |
|---|---|---|
| Lovostatin | Drug | – |
| Ibuprofen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10682216St George-Hyslop PH. Molecular genetics of Alzheimer's disease. Biol Psychiatry. 2000 Feb 1;47(3):183-99. doi: 10.1016/s0006-3223(99)00301-7.
- Background: PubMed 9343469Small GW, Rabins PV, Barry PP, Buckholtz NS, DeKosky ST, Ferris SH, Finkel SI, Gwyther LP, Khachaturian ZS, Lebowitz BD, McRae TD, Morris JC, Oakley F, Schneider LS, Streim JE, Sunderland T, Teri LA, Tune LE. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA. 1997 Oct 22-29;278(16):1363-71.
- Background: PubMed 9697923Bass MP, Yamaoka LH, Scott WK, Gaskell PC, Welsh-Bohmer KA, Roses AD, Saunders AM, Haines JL, Pericak-Vance MA. No association of alpha1-antichymotrypsin flanking region polymorphism and Alzheimer disease risk in early- and late-onset Alzheimer disease patients. Neurosci Lett. 1998 Jul 3;250(2):79-82. doi: 10.1016/s0304-3940(98)00398-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lovostatin and Ibuprofen in people with Alzheimer Disease, run by National Institute of Mental Health (NIMH) 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2008. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046358, which also lists 3 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 4 Mar 2008.