Development of a Novel Glutamate Receptor Ligand for PET Scans in Neuropsychiatric Systemic Lupus Erythematosus

Completed

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT02456168

Run by

Northwell Health

People needed

30

Starts

2014-01-21

Expected to finish

2020-10-28

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition.
• Increased disease activity within 8 weeks defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies.
• Any increase in steroid dose or addition of disease modifying agents within 8 weeks.
• Exceeding the weight limit on the MRI scanner.
• Suffering from claustrophobia.
• 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.
• Current use of anxiolytic, antidepressant or antipsychotic medications.
• Pregnant and/or lactating women
• 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.
• The presence of uncontrolled or severe hypertension, diabetes mellitus or liver disease that would increase the risk of increased toxicity from gadolinium contrast.

Where it is running

• The Feinstein Institute for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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