A recently approved therapy for Restless Leg Syndrome (RLS) used NeuroCog Trials’ Brief Assessment of Cognition (BAC) battery to help establish the safety profile of the compound. This is a novel and important use of cognition data in drug development, one that enhances the utility of cognition data beyond efficacy claims to now include establishing the safety profile of new medicines as well.
Richard Keefe, Ph.D., Founder and CEO of NeuroCog Trials, said “We believe that this is an important application of neuropsychological testing in drug development. A more complete understanding of the impact of new medicines on cognitive functioning helps to inform all interested parties – from patients and pharmaceutical companies, to regulatory authorities and payers.”
The BAC was originally developed and validated at Duke University Medical Center as a test battery to measure cognition in patients with schizophrenia patients. This is the first FDAapproved therapy to use the BAC as a tool to help establish a safety profile. The BAC is concise, multidimensional measure of cognition comprised of six subtests that can be administered in 30 minutes. It includes measures of processing speed, reasoning and problem-solving, verbal memory, and working memory. Two other versions of the BAC, the Brief Assessment of Cognition in Schizophrenia (BACS) and the Brief Assessment of Cognition in Affective Disorders (BAC-A), are also available.