Researchers at San Francisco-based Brain Plasticity, Inc. (BPI) have begun a multi-center study to evaluate the effects of a computerized, brain-plasticity-based program designed to address the cognitive issues associated with schizophrenia. The clinical trial, e-CAeSAR (Evaluation of a Cognitively Adaptive e-treatment in Schizophrenia-diagnosed Adults: A Remediation-based Approach), is being funded by the National Institute of Mental Health (NIMH) and will be conducted at eleven research centers in the U.S. in collaboration with experienced investigators from the Schizophrenia Trials Network (STN).
Cognitive impairment is a devastating component of schizophrenia that affects virtually all persons who are diagnosed. The NIMH estimates that nearly 40 percent ($44 billion) of schizophrenia's total cost involves lost time from work for patients and care providers, and places high demands on social services. This makes schizophrenia the most costly mental illness in the United States.
The "e-CAeSAR" trial is the first time neuroscientists will work with U.S. Food and Drug Administration representatives to evaluate Brain Plasticity's program. Pharmaceutical companies have tested drugs in development to alleviate the cognitive symptoms of schizophrenia; thus far none have been FDA-approved as efficacious.
"Cognitive impairment in schizophrenia sorely needs attention, yet there are no FDA-approved treatments for this devastating aspect of the illness," notes Dr. Richard Keefe of the Schizophrenia Trials Network (STN). These cognitive impairments can limit the ability of persons with schizophrenia to process new information accurately and quickly, make effective decisions and remember key information. Coupled together, these symptoms can severely impair patients' abilities to perform everyday activities, live independently, gain employment and sustain social relationships. It is commonly believed that the most significant symptoms of schizophrenia are delusions and/or hallucinations, yet these represent only a fraction of the symptoms.
"We are honored to work with world-renowned researchers who are part of the Schizophrenia Trials Network. We hope that our efforts encourage other scientists to develop and study new cognitive treatments to support persons with schizophrenia and their families," states BPI Chief Operating Officer Dr. Henry Mahncke, whose organization was founded in 2009 to support the rapid development and evaluation of innovative neuroscience-based brain health solutions.
"We are excited to participate in this long-awaited, much-needed seminal trial of cognitive remediation for individuals with schizophrenia. Cognitive remediation is a potential breakthrough treatment that along with more traditional pharmaceutical and psychotherapeutic modalities may significantly impact the lives of those living with schizophrenia, their families and society as a whole, said Jennifer Hoblyn, MD, MPH, who directs Inpatient Mental Health Services at the Veterans Affairs Medical Center in Palo Alto, CA., an investigator in the e-CAeSAR study.