Skip to main content
Delfa

← Trials/Trial dossier/NCT00004845

CompletedPhase 2 / PHASE3

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

A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease

Assets

Naproxen / Rofecoxib

Listed sites

40

Recruiting sites

-

Enrollment

-

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 13-26

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIA0021
NCT IDNCT00004845

Timeline

Milestones

Study first posted2000-02-29estimated
Primary completion2001-12actual (month precision)
Study completion2001-12actual (month precision)
Last update posted2009-12-11estimated

Assets

Drug assets

NaproxenRofecoxib

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.