# 2/5-The Autism Biomarkers Consortium for Clinical Trials

> **NIH NIH U19** · YALE UNIVERSITY · 2022 · $914,035

## 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 fu...

## Key facts

- **NIH application ID:** 10439669
- **Project number:** 5U19MH108206-07
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** CHARLES Alexander NELSON
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $914,035
- **Award type:** 5
- **Project period:** 2015-07-17 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10439669

## Citation

> US National Institutes of Health, RePORTER application 10439669, 2/5-The Autism Biomarkers Consortium for Clinical Trials (5U19MH108206-07). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10439669. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*