Effect of Indomethacin on the Progression of Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborators:
American Health Assistance Foundation
Brain Foundation of the Netherlands
Netherlands Alzheimer Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00432081
First received: February 5, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: indomethacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Indomethacin on the Progression of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Estimated Enrollment: 160
Study Start Date: May 2000
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432081

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
American Health Assistance Foundation
Brain Foundation of the Netherlands
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00432081     History of Changes
Other Study ID Numbers: A2001-15-DDJ, 917.46.331
Study First Received: February 5, 2007
Last Updated: February 5, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Dementia
Inflammation
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Drug Therapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anti-Inflammatory Agents
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014