Effect of Indomethacin on the Progression of Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is determine whether indomethacin is able to retard disease progression in patients with mild to moderate Alzheimer's disease.

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Detailed Description

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Previous research indicates that inflammation plays a role in the pathogenesis of Alzheimer's disease (AD), and nonsteroidal anti-inflammatory drugs (NSAIDs) may retard the progression of the disease.

Comparison(s): Cognitive decline of patients with mild to moderate AD receiving the NSAID indomethacin, compared to cognitive decline of patients with mild to moderate AD receiving placebo, during a one-year period.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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indomethacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No