Autism Biomarkers Consortium for Clinical Trials – Data Collection at UCLA with Shafali Spurling Jeste, MD
Government, non-profit, and other private partners will fund a multi-year project to develop and improve clinical research tools for studying autism spectrum disorder (ASD). The project will receive a total of $28 million over the next four years to test and refine clinical measures of social impairment in ASD in order to better evaluate potential behavioral and drug therapies. It is supported by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), the Foundation for the NIH (FNIH), the Simons Foundation Autism Research Initiative (SFARI), and others.
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 percent of children worldwide. A lack of defined measures of change in social functioning makes it difficult for researchers to develop interventions for the core social impairment of autism. The ultimate goal of this study is to produce a set of measures that can be used as biomarkers of social impairment in ASD and that could serve as indicators of long-term clinical outcome in clinical and drug development studies.
The four-year partnership will help fund a study of preschool (3-5 years) and school-aged (6-11 years) children with Autism Spectrum Disorders (ASD) to identify non-invasive biological markers (biomarkers) that could help physicians diagnose the condition, track progression and assess the effectiveness of treatment.
The study, which is led by a team of researchers from Yale School of Medicine, including Dr. Shafali Spurling Jeste, the Collaborating Implementation Site Director for UCLA, will collect data from children over a 24-week period and evaluate key facets of social-communication in ASD using a number of measures—assessments of social impairment, such as clinician, caregiver and lab-based tools, as well as neurophysiological measures, such as eye tracking and electrophysiological (EEG). Researchers will also collect blood (DNA) samples from ASD subjects, including parents of ASD subjects, 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 and Yale University.
“Autism is a disorder with a tremendous amount of variability from one child to the next,” said Jeste. “We’re trying to find brain-based measures that will allow us to identify subgroups within the autism spectrum, so that physicians can tailor treatments for the specific type of autism that each patient presents and can do so early enough in the patient’s life to make the most difference,” Jeste said. “Unfortunately, treatment today for autism is based on what a family’s insurance plan provides, and children get the interventions that the plan covers, whether or not they’re useful. This study is the first step to bring the promise of precision medicine to treatment for autism spectrum disorder.”
In addition to the behavioral measures and biomarker data, this community resource will also include blood samples from subjects and their parents for use in future genetic studies. Data and resource sharing are key components of this Consortium project. All data generated in the project will be made available for other researchers to view and analyze through the NIH-funded National Database for Autism Research and the NIMH Repository and Genomics Resource.
Other UCLA participants are Scott Johnson, a psychology professor; Catherine Ann Sugar, an associate professor in residence at the Fielding School of Public Health and the Semel Institute for Neuroscience and Human Behavior; Gerhard Hellemann, adjunct assistant professor in psychiatry; and Damla Senturkan, an associate professor of biostatistics.
To read more about this consortium, check out these links:
To learn more about this study and how to participate in this study, contact the Jeste Lab at: (310) 825-8738. Visit the Jeste Lab website at: http://www.semel.ucla.edu/jeste-lab