Effect of Indomethacin on the Progression of Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Effect of Indomethacin on the Progression of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432081
• Other study ID #: A2001-15-DDJ
• Secondary ID: 917.46.331
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2007
• Last updated: February 5, 2007
• Start date: May 2000
• Est. completion date: August 2005

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• indomethacin

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University	American Health Assistance Foundation, Netherlands Alzheimer Foundation, Netherlands Brain Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

McGeer PL, McGeer EG. NSAIDs and Alzheimer disease: epidemiological, animal model and clinical studies. Neurobiol Aging. 2007 May;28(5):639-47. Epub 2006 May 11. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Cognitive subscale of the Alzheimer’s Disease Assessment Scale at 12 months.
Secondary	Score on the Noncognitive subscale of the Alzheimer’s Disease Assessment Scale at 12 months
Secondary	Score on the Clinician Interview-Based Impression of Change with caregiver input at 12 months
Secondary	Score on the Mini-Mental State Examination at 12 months
Secondary	Score on the Neuropsychiatric Inventory at 12 months
Secondary	Score on the The Interview for Deterioration in Daily living activities in Dementia at 12 months
Secondary	The occurrence of adverse events during 12 months of treatment