The ERP Biomarker Qualification Consortium announced the publication of all data (https://doi.org/10.1016/j.schres.2023.02.018) from a large biomarker study of subjects with schizophrenia and matched healthy volunteers.
The study (EBS-A) was performed with 161 subjects, 80 who met the clinical criteria for schizophrenia and 81 subjects who were matched for age and gender. Each study participant made three visits to one of four clinical study sites. After it was determined that they met the inclusion criteria, the subjects underwent a battery of neuropsychological assessments to quantify their cognitive and psychiatric status. Then on visits two and three they were administered five separate electroencephalography (EEG) and event-related potential (ERP) tests using an advanced device called COGNISION®. The device records electrical activity from the brain and automatically quantifies over 100 electrophysiologic parameters.
The EEG/ERP tests used in this study are commonly performed in many academic research labs and the outputs have been previously well characterized. The novel contributions from this study are;
- the most commonly used EEG/ERP assessments were all performed in a single study on the same subjects,
- subjects were tested at different sites using the same equipment and methods,
- all analyses were performed using an automated data analysis pipeline, and
- all of the tests were reproduced on two separate visits to quantify test-retest variability.
The published results from this study will provide;
- baseline EEG/ERP measures for subjects with schizophrenia to compare to healthy subjects,
- differences between these populations for the EEG/ERP measures, and
- test-retest variability metrics that are critical in properly powering an interventional trial.
"The results of this study demonstrate the effectiveness of precompetitive consortia in transitioning the drug development community to a precision medicine approach to treating psychiatric patients", said Dr. Daniel Javitt, a Scientific Advisor to the Consortium.
The study was performed at four clinical study sites that are often selected by pharma companies for their early development programs, (CenExel HRI, CenExel CNS Garden Grove, CenExel CNS Torrance, and New York State Psychiatric Institute (NYPSI). "We have performed many EEG/ERP assessments in pharma-sponsored studies at our study sites, but this is the first time we have used standardized equipment, methods, and an automated data analysis process across all sites", said Dr. Larry Ereshefsky, a Scientific Advisor to the Consortium and the CSO for Clinical Sciences at CenExel and Follow the Molecule LLC.
The published results include a large number of EEG/ERP parameters that equal or exceed the quality of results reported from top academic centers. Along with the publication, all study data has been made available to academic researchers and the larger pharma community. "This study proves that complex EEG/ERP testing can reliably be performed in many early-phase clinical trials of drugs to treat serious brain disorders", said Dr. Marco Cecchi, CSO for Cognision.
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