The ongoing goal of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to establish electroencephalography (EEG) and eye-tracking (ET) biomarkers that can be used for stratification and/or as sensitive and reliable objective assays related to social function in autism spectrum disorder (ASD) clinical trials. This renewal application seeks to further validate promising measures through three studies designed to enhance and extend the original ABC-CT study: (1) a confirmation study of the original findings in a new cohort using similar design (T1: Baseline, T2: 6 weeks post baseline, T3: 24 weeks post baseline) and sample size/characteristics (200 with ASD, 200 with typical development (TD)); (2) a follow-up study of the original cohort (N=399) to re-administer the biomarker and clinical batteries 2.5-4 years after original ABC-CT enrollment; (3) a feasibility study of parallel EEG and ET biomarkers in preschool-aged (3-5-year-old) children (25 with ASD, 25 with TD). The biomarker and clinical batteries measure key facets of social-communication in ASD using well- validated paradigms appropriate for the intended developmental and cognitive range. The study will rely on the same leadership and five Collaborating Implementation Sites (?Sites?) from the first phase, all highly experienced in multi-site collaborative clinical research using the proposed clinical, EEG, and ET methodologies. The Data Coordinating Core (DCC) will provide a secure informatics infrastructure for communication and data integration across the consortium to ensure organized data management, quality control, and reliable upload to the National Database for Autism Research (NDAR) and NIH Data Repositories. The Data Acquisition and Analysis Core (DAAC) will oversee consistent use of scientific standards and methodological rigor for data acquisition, processing, and analytics. The Administrative Core, in coordination with federal partners in this cooperative agreement, will oversee the operations of the sites, DCC, and DAAC to ensure methodologically and ethically rigorous, efficient completion of study aims: 1) In the confirmation study with a new cohort, evaluate whether EEG and ET measures, individually or in combination, have utility as stratification biomarkers and/or sensitive, reliable measures of change in clinical trials; 2) In the follow-up study of the original ABC-CT cohort, assess long-term stability, sensitivity to change, and longitudinal predictive value of the markers; 3) In the feasibility study, determine the viability of parallel EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to further develop promising biomarkers to advance qualification with the FDA Biomarker Qualification Program.

Public Health Relevance

This renewal of the Autism Biomarkers Consortium for Clinical Trials seeks to further validate a set of reliable electrophysiological and eye-tracking biomarkers to facilitate clinical trials evaluating treatments for autism spectrum disorder (ASD). Sensitive, reliable, and objective biomarkers related to social function are needed to support development of individualized, effective treatment methods and, ultimately, improve outcomes for individuals with ASD.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZMH1)
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Gilotty, Lisa
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Yale University
Schools of Medicine
New Haven
United States
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Kang, Erin; Keifer, Cara M; Levy, Emily J et al. (2018) Atypicality of the N170 Event-Related Potential in Autism Spectrum Disorder: A Meta-analysis. Biol Psychiatry Cogn Neurosci Neuroimaging 3:657-666
Webb, Sara Jane; Neuhaus, Emily; Faja, Susan (2017) Face perception and learning in autism spectrum disorders. Q J Exp Psychol (Hove) 70:970-986
McPartland, James C (2017) Developing Clinically Practicable Biomarkers for Autism Spectrum Disorder. J Autism Dev Disord 47:2935-2937
Tremblay, S├ębastien; Sharika, K M; Platt, Michael L (2017) Social Decision-Making and the Brain: A Comparative Perspective. Trends Cogn Sci 21:265-276
Varcin, Kandice J; Jeste, Shafali S (2017) The emergence of autism spectrum disorder: insights gained from studies of brain and behaviour in high-risk infants. Curr Opin Psychiatry 30:85-91
Shic, Frederick (2016) Eye Tracking as a Behavioral Biomarker for Psychiatric Conditions: The Road Ahead. J Am Acad Child Adolesc Psychiatry 55:267-8
McPartland, James C (2016) Considerations in biomarker development for neurodevelopmental disorders. Curr Opin Neurol 29:118-22