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October 11, 2006

Cognitive Function in SLE

IRB Number: 26086

Institutional Review Board
Hospital for Special Surgery


The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Melanie J. Harrison, MD, MS

Co-Investigators

Michael D. Lockshin, MD
Debbie Miller
Katy Flynn-Meketon
Ania Rodney
Jamie Weiss
Janine Fernandez

Summary

This study will examine problems with thinking, memory, reaction time, concentration and problem solving (known as cognitive function) in patients with systemic lupus erythematosus, also known as SLE or lupus.  We will compare cognitive function in male and female lupus patients from different ethnic, socioeconomic and educational backgrounds.  The study will take place over a two-year period for a total of five study visits which take place every six months.  We will enroll 67 lupus patients and 67 non-SLE control subjects which will be matched in age (±5 years), gender, ethnicity, and educational background.  This data will be combined with data from the other participating centers (University of Texas Health Sciences Center-San Antonio and Johns Hopkins Medical Institutes) for a total of 200 SLE subjects and 200 healthy controls.

At each study visit, there will be a physical examination performed by a physician who has special expertise in providing care for patients with lupus.  Blood and urine samples will be collected at each visit, and tested for specific biological markers (such as antibodies) associated with SLE.  Additionally, neuropsychological tests (similar to intelligence tests) will be performed at each visit to test memory, concentration, and problem solving skills.  Some portions of the test will be administered on a computer, and some will be given by means of pencil and paper.

Subjects will receive $25.00 per visit as a courtesy for their time, and to cover transportation costs.

Inclusion/Exclusion Criteria

SLE Subjects
Inclusion

  • Age 18 years or greater
  • Males and females
  • Meet at least 4 of 11 ACR Criteria for the Classification of SLE
  • Can see a computer screen and push a mouse button

Exclusion

  • Prior experience with the ANAM testing
  • History of head trauma leading to loss of consciousness
  • Current illicit drug or alcohol abuse
  • Known structural brain lesion
  • Inability to complete study follow-up
  • Inability to give informed consent including inability to comprehend the purpose and procedures of the study (e.g., active psychosis, dementia)
  • Refusal to participate

Non-SLE Control Subjects
One healthy control subject will be matched to each SLE subject by age (±5 years), education, gender, and ethnicity.  Exclusion criteria include all those listed above for the SLE subjects. In addition, controls will be excluded if they have clinical or laboratory abnormalities that could be consistent with the diagnosis of SLE. This will be determined by administering the Connective Tissue Disease Screening Questionnaire (CSQ) developed for population studies.

Contact Information

Study Coordinator
Jamie Weiss
212.606.1867





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