Effect of Indomethacin on the Progression of Alzheimer's Disease

February 5, 2007 updated by: Radboud University Medical Center
The purpose of this study is determine whether indomethacin is able to retard disease progression in patients with mild to moderate Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Netherlands Brain Foundation
Netherlands Alzheimer Foundation
American Health Assistance 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 2007

Last Update Submitted That Met QC Criteria

February 5, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2001-15-DDJ
  • 917.46.331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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