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Standard Electronic Biomarkers Validated for Schizophrenia

Brain cell networks

(Gerd Altmann, Pixabay)

17 Mar. 2023. A new study validates standard electronic instrument measures of healthy individuals and people with schizophrenia to enable reliable clinical trials for treating the disease. Results of the research, conducted by a consortium of pharmaceutical companies, appeared on 13 Mar. in the April 2023 issue of the journal Schizophrenia Research.

Advances in information technology are making possible faster and more accurate measurements of brain activity than before. One type of brain activity measurement, called an event-related potential, results from a change in electroencephalogram or EEG readings that track electric signal activity in the brain from electrodes worn on the skull. For clinicians treating schizophrenia, some of these event-related potentials or ERPs and quantitative EEG measures are already known and linked to deficits in specific brain signals or cognitive impairments associated with the disorder.

For mental health drug makers, these electronic and quantitative measures are important in evaluating new treatments, particularly in clinical trials, where evidence of change from the treatment is essential for gaining regulatory approval. Up to now, however, there are few standard ERP or quantitative EEG indicators for measuring the status of a person’s schizophrenia or other mental health disease, as well as assessing change in that individual’s condition.

The company Neuronetrix Solutions in Louisville, Kentucky is developer of the Cognision system that assesses ERPs and quantitative EEG measurements as electronic biomarkers or indicators of neurological disorders, including Alzheimer’s disease and schizophrenia. To help define standard ERP and quantitative EEG biomarkers for mental health disorders, the company in Mar. 2019 created the ERP Biomarker Qualification Consortium, bringing together seven developers of drugs to treat psychiatric diseases.

Correlated with cognition and symptom measurements

The group today has 10 drug maker members — Merck, Novartis, AbbVie, Astellas, Lundbeck, Anavex, Sage, Alkermes, Neurocrine, and Takeda — as well as Cognision, as Neuronetrix Solutions is now called. Collaborations like these to develop open industry standards are not considered anti-competitive collusion, and are encouraged in recent Food and Drug Administration guidance on creating tools for drug development.

The consortium sponsored a clinical trial enrolling 80 individuals diagnosed with schizophrenia, matched by age and sex to 81 healthy individuals at four different sites. The study team gave all participants EEG tests while measuring responses to different auditory stimuli and in a resting state, with data collected through a Cognision system. The researchers analyzed the measurements with a collection of response assessments for amplitude, latency, task accuracy, reaction times, and other indicators. The team also correlated the ERP and EEG data with cognition and symptom measurements for the sample of people with schizophrenia. In addition, the researchers retested participants on a third visit to measure for reliability, but not on all variables.

The authors say the study shows the capture of consistent electronic ERP and quantitative EEG measures is feasible across multiple clinical sites, with assessments provided in near real time to clinicians. Results from the assessments show ERP and quantitative EEG deficits in people with schizophrenia similar to findings from academic studies, which also correlate to cognitive and functional measures of schizophrenia. In addition, data collected from ERP and quantitative EEG retests show some variability, but in general good reproducibility of the results.

“We have performed many EEG/ERP assessments in pharma-sponsored studies at our study sites,” says Larry Ereshefsky, a scientific adviser to the ERP Biomarker Qualification Consortium in a group statement released through Cision, “but this is the first time we have used standardized equipment, methods, and an automated data analysis process across all sites.”

The findings are expected to provide key baseline quantitative measures for people with schizophrenia compared to healthy individuals and differences on specific ERP and quantitative EEG measures for these populations. And the test/retest results will provide metrics to help design and interpret culture clinical trials.

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