Effect of Indomethacin on the Progression of Alzheimer's Disease

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00432081

Collaborator

American Health Assistance Foundation (Other), Netherlands Brain Foundation (Other), Netherlands Alzheimer Foundation (Other)

160

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: indomethacin	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Effect of Indomethacin on the Progression of Alzheimer's Disease

Study Start Date :

May 1, 2000

Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Score on the Noncognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months []
Score on the Clinician Interview-Based Impression of Change with caregiver input at 12 months []
Score on the Mini-Mental State Examination at 12 months []
Score on the Neuropsychiatric Inventory at 12 months []
Score on the The Interview for Deterioration in Daily living activities in Dementia at 12 months []
The occurrence of adverse events during 12 months of treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem		Netherlands	6800 TA
2	Radboud University Medical Center	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

Radboud University Medical Center
American Health Assistance Foundation
Netherlands Brain Foundation
Netherlands Alzheimer Foundation

Investigators

Principal Investigator: Rene WM Jansen, MD, PhD, Radboud University Medical Center Nijmegen
Principal Investigator: Berry PH Kremer, MD, PhD, Radboud University Medical Center Nijmegen
Study Director: Danielle De Jong, MD, Radboud University Medical Center Nijmegen