Effect of Indomethacin on the Progression of Alzheimer's Disease

NCT00432081 | Completed Phase 3

• 2 other identifiers: A2001-15-DDJ917.46.331
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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

Interventions

indomethacin DRUG

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• American Health Assistance Foundation: collaborator
• Netherlands Brain Foundation: collaborator
• Netherlands Alzheimer Foundation: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 8351023 BACKGROUND

• 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.

  PMID: 16697488 BACKGROUND

• 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.

  PMID: 18213383 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Inflammation

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rene WM Jansen, MD, PhD

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

• Berry PH Kremer, MD, PhD

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

• Danielle De Jong, MD

  Radboud University Medical Center Nijmegen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 6, 2007
• Study Start: May 1, 2000
• Study Completion: August 1, 2005
• Last Updated: February 6, 2007

Record last verified: 2007-02

Locations

NL (2)