Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT02456168
Eligibility Criteria:
Inclusion Criteria:
1. Must be ≥18 and ≤55 years of age.
2. Must fulfill the current American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE.
3. Must be willing and able to sign informed consent.
4. Must have stable disease activity and medication doses for 8 weeks prior to screening.
Exclusion Criteria:
1. History of neurological diseases including head injury resulting in a loss of consciousness, strokes (secondary to hypertension, atherosclerosis, diabetes), seizures, toxic exposure, any difficulties at birth, mental retardation.
2. History of documented transient ischemic attacks within six months of screening.
3. Currently taking anti-convulsant medication.
4. Limited fluency with English that in the opinion of the investigator would limit the subject's performance on the ACR battery of cognitive tests or the N-back task chosen for the working memory task during the PET scan.
5. History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition.
6. Increased disease activity within 8 weeks defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies.
7. Any increase in steroid dose or addition of disease modifying agents within 8 weeks.
8. Exceeding the weight limit on the MRI scanner.
9. Suffering from claustrophobia.
10. Have any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, IUD's, shrapnel injuries.
11. Current use of anxiolytic, antidepressant or antipsychotic medications.
12. Pregnant and/or lactating women
13. A glomerular filtration rate less than ≤60 mL/min or any evidence of active renal disease from any cause that would put the subject at risk for increased toxicity from gadolinium contrast for the MRI study.
14. The presence of uncontrolled or severe hypertension, diabetes mellitus or liver disease that would increase the risk of increased toxicity from gadolinium contrast.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02456168
Study Brief:
Protocol Section:
NCT02456168