Official Title: “Effect of Indomethacin on the Progression of Alzheimer's Disease”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: indomethacin

Primary Measures

• Score on the Cognitive subscale of the Alzheimer’s Disease Assessment Scale at 12 months.

Secondary 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radboud University

Overall Clinical Trial Officials and Contacts

Rene WM Jansen, MD, PhD Principal Investigator Radboud University Medical Center Nijmegen  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00432081

Study ID Number: A2001-15-DDJ

ClinicalTrials.gov Identifier: NCT00432081

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)