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NCT00042523 · ClinicalTrials.gov registry record

Role of Antibodies in Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus

A clinical trial, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
61
Enrollment target

NCT00042523: Completed study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

NCT00042523 is a clinical trial that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00042523 has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
61 participants
Enrollment target

Study Summary

This study will examine the possible relationship between certain antibodies found in patients with systemic lupus erythematosus (SLE) and cognitive (thought processing) impairment in these patients. Antibodies are proteins produced by cells of the immune system to fight foreign invaders such as bacteria and viruses. In autoimmune diseases like SLE, however, the immune system produces antibodies against the body's own healthy tissues. Antibodies targeting the brain may cause cognitive dysfunction. Many patients with SLE have mild to severe cognitive impairment involving, for example, short- or long-term memory, thought processing and relating objects in time and space. Patients 18 years of age and older with SLE may be eligible for this study. Participants will undergo the following tests and procedures: * Medical history and physical examination, including blood and urine tests * Psychiatric interview and questionnaire to assess depression * Neuropsychological tests - answering questions given by an examiner or filling out a test form or questionnaire * Tests of cognitive function - answering questions given by an automated computer program or performing tasks using a computer mouse * Magnetic resonance imaging (MRI) of the brain - a test that uses strong magnetic fields and radio waves to generate images of the brain. The patient lies still on a stretcher inside a cylinder containing a magnetic field. The patient's head is stabilized with a plastic strap and foam pads. During the imaging, a substance called gadolinium-DTPA is injected into an arm vein through a catheter (thin plastic tube). This substance is used to enhance the images. Patients may also be asked to undergo an optional procedure called a lumbar puncture (spinal tap) to examine the relationship between cognitive impairment and the amount of antibodies in the cerebrospinal fluid (CSF)- fluid that circulates around the brain and spinal cord. For this procedure a small area of skin on the lower back

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2002-07
Est. Completion 2005-01

What the finished NCT00042523 record still lists

NCT00042523 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00042523 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00042523 about?

NCT00042523 is a clinical study titled "Role of Antibodies in Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus". This study will examine the possible relationship between certain antibodies found in patients with systemic lupus erythematosus (SLE) and cognitive (thought processing) impairment in these patients. Antibodies are proteins produced by cells of the immune system to fight foreign invaders such as bac...

What is the current status of trial NCT00042523?

This trial is currently completed. The enrollment target is 61 participants. The study started on 2002-07. Estimated completion is 2005-01.

Who is sponsoring clinical trial NCT00042523?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00042523, the US trial registry maintained by the National Library of Medicine. NCT00042523 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.