Alzheimer DiseasePhase 2/3NCT00004845
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
A Phase 2/3 study testing Rofecoxib and Naproxen in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 40 sites in United States.
Trial summary
The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Rofecoxib and Naproxen
- How many people
- Not given
- Where
- 40 sitesUnited States
- Study dates
- Start not givento Dec 2001
- Phase
- Phase 2/3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NINCDS/ADRDA criteria for probable AD
- MMSE between 13 and 26, inclusive
- Stable medical condition for 3 months
- Screening visit
- Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests
- Supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits
Show all 13Show fewer
- Fluent in English or Spanish
- Age greater than or equal to 55 years old
- Modified Hachinski of less than or equal to 4
- CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion
- Able to complete baseline assessments
- 6 years of education or work history sufficient to exclude mental retardation
- Able to ingest oral medication
Who cannot join
- Hypersensitivity to aspirin or NSAID
- Active peptic ulcer disease within 5 years
- Renal insufficiency with creatinine greater than 1.5
- Clinically significant liver disease
- Poorly controlled hypertension
- Congestive heart failure
Show all 9Show fewer
- Bleeding ulcer
- Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
- Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30329
Southwestern Vermont Medical Center
Bennington, Vermont, 05201
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, 33486
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44120
University of Texas, SW Medical Center
Dallas, Texas, 75390-9070
Baumel-Eisner Ft Lauderdale
Fort Lauderdale, Florida, 33321
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202-5266
University of California Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
Kansas University
Kansas City, Kansas, 66160
University of California, San Diego
La Jolla, California, 92037
University of Nevada
Las Vegas, Nevada, 89102
University of Kentucky
Lexington, Kentucky, 40536-0230
University of Southern California
Los Angeles, California, 90033-1039
University of California, Los Angeles
Los Angeles, California, 90095-1769
University of California, Davis
Martinez, California, 94553
Wein Center
Miami Beach, Florida, 33140
Baumel-Eisner Neuromedical Institute, MiamiBeach
Miami Beach, Florida, 33154
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646
Yale University, School of Medicine
New Haven, Connecticut, 06520
New York University Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Medical University of South Carolina
North Charleston, South Carolina, 29406
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Barrow Neurological Group
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97201-3098
Memorial Hospital of Rhode Island
Providence, Rhode Island, 02906
University of Rochester Medical Center
Rochester, New York, 14620
University of Washington
Seattle, Washington, 98108
Washington University
St Louis, Missouri, 63108-2293
ClinSearch, Inc
Summit, New Jersey, 07901
University of South Florida
Tampa, Florida, 33617
University of Arizona, Tucson
Tucson, Arizona, 85724-5023
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease
The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
Read the detailed description
Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (NSAIDs) may slow the rate of cognitive deterioration. We have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. The trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. A total of 320 patients will be enrolled in the trial and randomized to the three groups. Stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin E will be allowed. Patients with inflammatory diseases that might respond to the study medications will be excluded.
The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog). The attainment of significant endpoints will be examined as a secondary outcome measure. Other secondary measures include the CDR sum-of-boxes, Neuropsychiatric Inventory, the Quality of Life-AD and the ADCS pharmacoeconomic scale. The influence of HLA-DR (Human Leukocyte Antigen) genotype on clinical progression and response to treatment will also be examined.
- Conditions
- Alzheimer Disease
- Being tested
- Rofecoxib, Naproxen
- Keywords
- Anti-inflammatory
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RofecoxibDrug
NaproxenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2000 (estimated)
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Investigators
- Leon Thal, MD, Principal investigator, Alzheimer's Disease Cooperative Study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004845
- Sponsor's protocol ID
- IA0021
- Status last verified
- Jun 2009
- First submitted
- 28 Feb 2000
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003 Jun 4;289(21):2819-26. doi: 10.1001/jama.289.21.2819.
PubMed 12783912
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00004845
- Acronym / sponsor ID
- IA0021
- Conditions
- Alzheimer Disease
- Keywords
- Anti-inflammatory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 29 Feb 2000 (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 primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
Detailed description
Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (NSAIDs) may slow the rate of cognitive deterioration. We have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. The trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. A total of 320 patients will be enrolled in the trial and randomized to the three groups. Stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin E will be allowed. Patients with inflammatory diseases that might respond to the study medications will be excluded.
The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog). The attainment of significant endpoints will be examined as a secondary outcome measure. Other secondary measures include the CDR sum-of-boxes, Neuropsychiatric Inventory, the Quality of Life-AD and the ADCS pharmacoeconomic scale. The influence of HLA-DR (Human Leukocyte Antigen) genotype on clinical progression and response to treatment will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- NINCDS/ADRDA criteria for probable AD
- MMSE between 13 and 26, inclusive
- Stable medical condition for 3 months
- Screening visit
- Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests
Key exclusion criteria (9 listed)
- Hypersensitivity to aspirin or NSAID
- Active peptic ulcer disease within 5 years
- Renal insufficiency with creatinine greater than 1.5
- Clinically significant liver disease
- Poorly controlled hypertension
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 |
|---|---|---|
| Rofecoxib | Drug | – |
| Naproxen | 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 11 Dec 2009.
- Results publication: PubMed 12783912Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003 Jun 4;289(21):2819-26. doi: 10.1001/jama.289.21.2819.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Leon Thal, MD principal investigator
Alzheimer's Disease Cooperative Study
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rofecoxib and Naproxen in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 40 sites 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 13 inclusion and 9 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 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00004845, which also lists 1 linked publication.
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 11 Dec 2009.