A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
10. december 2009 opdateret af: National Institute on Aging (NIA)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Barrow Neurological Group
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Tucson, Arizona, Forenede Stater, 85724-5023
- University of Arizona, Tucson
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California
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Irvine, California, Forenede Stater, 92697-4285
- University of California Irvine Institute for Brain Aging and Dementia
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La Jolla, California, Forenede Stater, 92037
- University of California, San Diego
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Los Angeles, California, Forenede Stater, 90033-1039
- University of Southern California
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Los Angeles, California, Forenede Stater, 90095-1769
- University of California, Los Angeles
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Martinez, California, Forenede Stater, 94553
- University of California, Davis
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University, School of Medicine
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- Georgetown University Medical Center
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Baumel-Eisner Neuromedical Institute, Boca Raton
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Ft Lauderdale, Florida, Forenede Stater, 33321
- Baumel-Eisner Ft Lauderdale
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Jacksonville, Florida, Forenede Stater, 32225
- Mayo Clinic Jacksonville
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Miami Beach, Florida, Forenede Stater, 33140
- Wein Center
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Miami Beach, Florida, Forenede Stater, 33154
- Baumel-Eisner Neuromedical Institute, MiamiBeach
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Tampa, Florida, Forenede Stater, 33617
- University of South Florida
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West Palm Beach, Florida, Forenede Stater, 33407
- Premiere Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush Presbyterian St. Luke's Medical Center
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5266
- Indiana University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Kansas University
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0230
- University of Kentucky
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
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Missouri
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St. Louis, Missouri, Forenede Stater, 63108-2293
- Washington University
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- University of Nevada
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New Jersey
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Summit, New Jersey, Forenede Stater, 07901
- ClinSearch, Inc
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New York
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New York, New York, Forenede Stater, 10016
- New York University Medical Center
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New York, New York, Forenede Stater, 10032
- Columbia University
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Rochester, New York, Forenede Stater, 14620
- University of Rochester Medical Center
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Ohio
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Cleveland, Ohio, Forenede Stater, 44120
- University Hospitals of Cleveland
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Oregon
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Portland, Oregon, Forenede Stater, 97201-3098
- Oregon Health Sciences University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02906
- Memorial Hospital of Rhode Island
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29406
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37212-8646
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390-9070
- University of Texas, SW Medical Center
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
- Southwestern Vermont Medical Center
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Washington
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Seattle, Washington, Forenede Stater, 98108
- University of Washington
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Leon Thal, MD, Alzheimer's Disease Cooperative Study
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Primær færdiggørelse (Faktiske)
1. december 2001
Studieafslutning (Faktiske)
1. december 2001
Datoer for studieregistrering
Først indsendt
28. februar 2000
Først indsendt, der opfyldte QC-kriterier
28. februar 2000
Først opslået (Skøn)
29. februar 2000
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. december 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2009
Sidst verificeret
1. juni 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurokognitive lidelser
- Neurodegenerative sygdomme
- Demens
- Tauopatier
- Alzheimers sygdom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Cyclooxygenase 2-hæmmere
- Gigthæmmende midler
- Naproxen
- Rofecoxib
Andre undersøgelses-id-numre
- IA0021
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .