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

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Alzheimer's Disease Cooperative Study (ADCS)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00004845

Purpose

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	Intervention	Phase
Alzheimer Disease	Drug: Rofecoxib Drug: Naproxen	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Naproxen Naproxen sodium Rofecoxib

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Study Completion Date:	December 2001
Primary Completion Date:	December 2001 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004845

Show 40 Study Locations

Sponsors and Collaborators

National Institute on Aging (NIA)

Alzheimer's Disease Cooperative Study (ADCS)

Investigators

Principal Investigator:

Leon Thal, MD

Alzheimer's Disease Cooperative Study

More Information

Publications:

Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ. Effects of Rofecoxib or Naproxen vs Placebo on Alzheimer Disease Progression: A Randomized Controlled Trial. JAMA. 2003 Jun 4;289(21):2819-26.

ClinicalTrials.gov Identifier:	NCT00004845 History of Changes
Other Study ID Numbers:	IA0021
Study First Received:	February 28, 2000
Last Updated:	December 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Anti-inflammatory

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012