The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is a multicenter research study based at Yale University that spans Duke University, Boston Children’s Hospital, the University of Washington/Seattle Children’s Research Institute and the University of California, Los Angeles. The aim of the consortium is to develop reliable and objective measurements of social function and communication in people with autism.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that affects social interaction and communication skills and can cause restricted and repetitive behaviors. Approximately 1 percent of children throughout the world have ASD, each with his or her own unique combination of symptoms and levels of function. It is this extensive “spectrum” of symptoms and severity that has proven to be particularly challenging for clinical research.
Currently, ASD is diagnosed and treated based on information gathered from clinical assessments and parent questionnaires. ABC-CT will add to this pool of knowledge by developing a more objective battery of tools to measure social function. Using EEG to measure brain function, eye-tracking technology to measure visual attention and automated recording techniques to assess behavior and speech, children aged 6 to 11 will be monitored over a six-month period. In addition to the behavioral measures and biomarker data, this community resource will also include DNA samples from children with ASD and their parents for use in future genetic studies.
The consortium will establish a technical and data infrastructure for reliably measuring social function, allowing the collaborating sites to work together as a single unit. The goal is to create a set of measures that can be used in clinical trials to determine which treatments are best for which patients and who will benefit from a particular treatment. The ultimate goal is to validate a set of tools that will enable clinicians to objectively measure and predict how children with ASD respond to treatment.
ABC-CT receives funding support from SFARI in addition to the National Institutes of Health (NIH), the National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Disorders and Stroke (NINDS), the Foundation for the NIH (FNIH) and other partners.
The project will be conducted in close collaboration with multiple partners and stakeholders —including SFARI, the FNIH Biomarkers Consortium, the U.S. Food and Drug Administration, Janssen Research and Development, LLC, and the European Autism Interventions – A Multicentre Study for Developing New Medications (EU-AIMS) — to provide critical input and coordination among public and private sector partners.