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CompletedPhase 3

Effect of Indomethacin on the Progression of Alzheimer's Disease

Asset

indomethacin

Listed sites

2

Recruiting sites

-

Enrollment

160

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale

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

Secondary917.46.331
Org study IDA2001-15-DDJ
NCT IDNCT00432081

Timeline

Milestones

Study start2000-05 (month precision)
Study completion2005-08 (month precision)
Study first posted2007-02-06estimated
Last update posted2007-02-06estimated

Assets

Drug assets

indomethacin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•The patient will satisfy the DSM-IV criteria for dementia of the Alzheimer's type.
•The patient will satisfy the NINCDS/ADRDA criteria for the clinical diagnosis of probable Alzheimer's disease (Appendix I).
•The severity of dementia for each patient will be quantified by a Mini-Mental State Examination (MMSE) score between 10 and 26 (both inclusive).
•The patient is living at home or in a home for the elderly.
•The patient has a responsible caregiver who is able to provide information about the patient's functional status.
•Written informed consent is obtained from the patient or the legally accepted representative

Exclusion criteria

•The patient satisfies the NINDS-AIREN criteria for probable vascular dementia.
•A known exaggerated pharmacological sensitivity or allergy to NSAID's.
•History of peptic ulceration, gastric surgery or gastrointestinal bleeding.
•Current diagnosis of active peptic ulceration.
•Current diagnosis of severe and unstable cardiovascular disease.
•Current diagnosis of renal failure.
•Advanced, severe and unstable disease of any type, other than Alzheimer's disease, that may interfere with primary and secondary variable evaluations, including a medical condition which should be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
•Intake of any of the following concomitant medications: salicylates, coumarin derivatives, ACE-inhibitors, loop diuretics.
•Intake of any of the following concomitant medications more than two months immediately prior or during the study: NSAID's, systemic corticosteroids.
•Intake of any of the following concomitant medications with a possible effect on cognition: estrogen, deprenyl, vitamin E, neuroleptics, anticholinergics. Patients using stable doses of cholinesterase inhibitors were eligible, with the provision that the dose should not be changed during the study. Cholinesterase inhibitors could not be initiated during the study.
•Excessive use of alcohol (more than 5 units per day)
•The patient is, either alone or with the aid of a caregiver, not able to reliably take the medication.

Endpoints (7)

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.

Coverage by outcome category

Other (unclassified)
3
Global cognition
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Score on the Mini-Mental State Examination at 12 months

Mini-Mental State Examination (MMSE)

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Score on the Neuropsychiatric Inventory at 12 months

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Score on the Clinician Interview-Based Impression of Change with caregiver input at 12 months

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

The occurrence of adverse events during 12 months of treatment

event count, event

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months.

descriptive

Secondary/protocol endpoint/low confidence

Score on the Noncognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months

descriptive

Secondary/protocol endpoint/low confidence

Score on the The Interview for Deterioration in Daily living activities in Dementia at 12 months

ratio, descriptive

Publications (3)

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.