Development of a Novel Glutamate Receptor Ligand for PET Scans in Neuropsychiatric Systemic Lupus… (NCT02456168) | Clinical Trial Compass
CompletedNot Applicable
Development of a Novel Glutamate Receptor Ligand for PET Scans in Neuropsychiatric Systemic Lupus Erythematosus
United States30 participantsStarted 2014-01-21
Plain-language summary
Cognitive impairment occurs in as many as 80% of lupus patients and affective disorders, depression and anxiety, are also common. Both of these problems contribute significantly to disease burden and disability. Associations between serum anti-NMDAR Aab and cognitive and behavioral changes in human SLE have remained controversial, however, elevated titers of these Aabs in cerebrospinal fluid (CSF) correlate with severe central nervous system manifestations, such as coma and psychosis. The aim is to study the progression of disease (cognitive and behavioral impairment) over a 2 year period in SLE subjects with neuropsychologic and behavioral testing and correlates of disease progression using resting FDG-PET and serum Anti-NMDAR Aab. The correlations between hippocampal hypermetabolism, Anti-NMDAR Aab and memory impairment observed in the cross-sectional studies will be validated by baseline measurements in the proposed studies.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Must be ≥18 and ≤55 years of age.
✓. Must fulfill the current American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE.
✓. Must be willing and able to sign informed consent.
✓. Must have stable disease activity and medication doses for 8 weeks prior to screening.
Exclusion criteria
✕. 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.
✕. History of documented transient ischemic attacks within six months of screening.
✕. Currently taking anti-convulsant medication.
✕. 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.
What they're measuring
1
Changes in brain activity
Timeframe: hippocampal metabolism from baseline over the 2 years