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Alzheimer DiseasePhase 3NCT00432081

Effect of Indomethacin on the Progression of Alzheimer's Disease

A Phase 3 study testing indomethacin in people with Alzheimer Disease, run by Radboud University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
indomethacin
How many people
160 participants
Where
2 sitesNetherlands
Study dates
May 2000to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Rijnstate Hospital

    Arnhem, 6800 TA

  • Radboud University Medical Center

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

The purpose of this study is determine whether indomethacin is able to retard disease progression in patients with mild to moderate Alzheimer's disease.

Read the 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.

Being tested
indomethacin
Keywords
Dementia, Inflammation, Anti-Inflammatory Agents, Anti-Inflammatory Agents, Non-Steroidal, Drug Therapy
Medical subject headings
Alzheimer Disease, Dementia, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • indomethacinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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

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

  3. Score on the Mini-Mental State Examination at 12 months

  4. Score on the Neuropsychiatric Inventory at 12 months

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

  6. The occurrence of adverse events during 12 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2007 (estimated)
  2. Study startMay 2000
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00432081
Sponsor's protocol ID
A2001-15-DDJ
Other IDs
917.46.331
Status last verified
Feb 2007
First submitted
5 Feb 2007
Last updated
6 Feb 2007
Results posted
No

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. doi: 10.1212/wnl.43.8.1609.

    PubMed 8351023

  • 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.

    PubMed 16697488

  • 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.

    PubMed 18213383

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing indomethacin in people with Alzheimer Disease, run by Radboud University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00432081, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2007.

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