Yale School of Medicine researchers will lead a national multi-center study of preschool and school-aged children with Autism Spectrum Disorders (ASD) to identify non-invasive biological markers (biomarkers) that could help physicians diagnose, track, and assess treatments in autism patients.
The study is part of a new four-year, public-private collaboration announced July 20 between the National Institutes of Mental Health (NIMH, a component of the National Institutes of Health), the Foundation for the National Institutes of Health (FNIH), the Simons Foundation Autism Research Initiative (SFARI), and multiple partners and stakeholders. Supported by a $2 million grant from SFARI and managed under the FNIH Biomarkers Consortium, this project is part of a $28 million NIH initiative.
Led by principal investigator James McPartland, associate professor at the Yale Child Study Center at Yale School of Medicine, the multi-site research team will collect data from children with ASD over a 24-week period and evaluate key facets of social communication in ASD using a number of measures -- assessing social function using clinician, caregiver, and lab-based tools, and measuring neurophysiological responses via eye-tracking and electrophysiological (EEG) tests.
The researchers will also collect blood (DNA) samples from patients with ASD as well as their parents for future genomic analyses. Data collection will take place across five sites: Duke University, Boston Children's Hospital, University of California at Los Angeles, University of Washington/Seattle Children's Research Institute, and Yale.
"We are truly excited to carry out this ambitious and important project," said McPartland. "We will create methods to fundamentally advance treatment research in autism."
ASD affects early brain development and can present signs and symptoms within the first two years of life. It is estimated that ASD affects 1% of children worldwide. A lack of objective measures of change in social functioning makes it difficult for researchers to develop interventions for the core social impairment of autism.
"Our ultimate goal is to produce a set of measures that can be used as biomarkers of social and communicative function in ASD and that could serve as indicators of long-term clinical outcome in clinical and drug development studies," said McPartland.
In addition to funding from SFARI, the FNIH Project Team for the ASD Biomarkers Project will receive technical input and expert advice from Janssen Research and Development, LLC, and the European Autism Interventions-A multicenter Study for Developing New Medications (EU-AIMS) for the duration of the project. The foundation will work closely with SFARI, the U.S. Food and Drug Administration, Janssen Research and Development, LLC, and EU-AIMS to provide critical input and coordination among the public and private sector partners for this effort.
The study is also supported by a Yale Clinical and Translational Science Award (CTSA) grant from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health.