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A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004845
Recruitment Status : Completed
First Posted : February 29, 2000
Last Update Posted : December 11, 2009
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by:
National Institute on Aging (NIA)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Rofecoxib Drug: Naproxen Phase 2 Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004845


Locations
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Sponsors and Collaborators
National Institute on Aging (NIA)
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
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Principal Investigator: Leon Thal, MD Alzheimer's Disease Cooperative Study
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00004845    
Other Study ID Numbers: IA0021
First Posted: February 29, 2000    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: June 2009
Keywords provided by National Institute on Aging (NIA):
Anti-inflammatory
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Naproxen
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors