# The Autism Biomarkers Consortium for Clinical Trials

> **NIH NIH U19** · YALE UNIVERSITY · 2022 · $7,948,772

## Abstract

Project Summary/Abstract
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
bio...

## Key facts

- **NIH application ID:** 10439663
- **Project number:** 5U19MH108206-07
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** James Charles McPartland
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $7,948,772
- **Award type:** 5
- **Project period:** 2015-07-17 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10439663

## Citation

> US National Institutes of Health, RePORTER application 10439663, The Autism Biomarkers Consortium for Clinical Trials (5U19MH108206-07). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10439663. Licensed CC0.

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