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Effect of Indomethacin on the Progression of Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

indomethacin

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Inflammation, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Drug Therapy

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rijnstate Hospital
Radboud University Medical Center

Outcomes

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

Full Information

NCT ID

NCT00432081

First Posted

February 5, 2007

Last Updated

February 5, 2007

Sponsor

Radboud University Medical Center

Collaborators

American Health Assistance Foundation, Netherlands Brain Foundation, Netherlands Alzheimer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00432081

Brief Title

Effect of Indomethacin on the Progression of Alzheimer's Disease

Official Title

Effect of Indomethacin on the Progression of Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

Collaborators

American Health Assistance Foundation, Netherlands Brain Foundation, Netherlands Alzheimer Foundation

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Dementia, Inflammation, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

indomethacin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Score on the Noncognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months

Title

Score on the Clinician Interview-Based Impression of Change with caregiver input at 12 months

Title

Score on the Mini-Mental State Examination at 12 months

Title

Score on the Neuropsychiatric Inventory at 12 months

Title

Score on the The Interview for Deterioration in Daily living activities in Dementia at 12 months

Title

The occurrence of adverse events during 12 months of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rene WM Jansen, MD, PhD

Organizational Affiliation

Radboud University Medical Center Nijmegen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Berry PH Kremer, MD, PhD

Organizational Affiliation

Radboud University Medical Center Nijmegen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Danielle De Jong, MD

Organizational Affiliation

Radboud University Medical Center Nijmegen

Official's Role

Study Director

Facility Information:

Facility Name

Rijnstate Hospital

City

Arnhem

ZIP/Postal Code

6800 TA

Country

Netherlands

Facility Name

Radboud University Medical Center

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

8351023

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. doi: 10.1212/wnl.43.8.1609.

Results Reference

background

PubMed Identifier

16697488

Citation

McGeer PL, McGeer EG. NSAIDs and Alzheimer disease: epidemiological, animal model and clinical studies. Neurobiol Aging. 2007 May;28(5):639-47. doi: 10.1016/j.neurobiolaging.2006.03.013. Epub 2006 May 11.

Results Reference

background

PubMed Identifier

18213383

Citation

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. doi: 10.1371/journal.pone.0001475.

Results Reference

derived

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Effect of Indomethacin on the Progression of Alzheimer's Disease

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