Effect of Indomethacin on the Progression of Alzheimer's Disease - Full Text View

Sponsor:	Radboud University
Collaborators:	American Health Assistance Foundation Brain Foundation of the Netherlands Netherlands Alzheimer Foundation
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00432081

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Indomethacin on the Progression of Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Indomethacin

U.S. FDA Resources

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

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:

Rogers J, Kirby LC, Hempelman SR, Berry DL, McGeer PL, Kaszniak AW, Zalinski J, Cofield M, Mansukhani L, Willson P, et al. Clinical trial of indomethacin in Alzheimer's disease. Neurology. 1993 Aug;43(8):1609-11.

McGeer PL, McGeer EG. NSAIDs and Alzheimer disease: Epidemiological, animal model and clinical studies. Neurobiol Aging. 2006 May 10; [Epub ahead of print]

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

de Jong D, Jansen R, Hoefnagels W, Jellesma-Eggenkamp M, Verbeek M, Borm G, Kremer B. No effect of one-year treatment with indomethacin on Alzheimer's disease progression: a randomized controlled trial. PLoS ONE. 2008 Jan 23;3(1):e1475.

Study ID Numbers:	A2001-15-DDJ, 917.46.331
Study First Received:	February 5, 2007
Last Updated:	February 5, 2007
ClinicalTrials.gov Identifier:	NCT00432081 History of Changes
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:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Neurodegenerative Diseases
Brain Diseases
Gout Suppressants
Tocolytic Agents
Mental Disorders
Sensory System Agents
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Dementia
Nervous System Diseases
Alzheimer Disease
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Tauopathies
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009