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ABC-CT Pre-School Feasibility Study - Trial NCT06413316

Access comprehensive clinical trial information for NCT06413316 through Pure Global AI's free database. This phase not specified trial is sponsored by Yale University and is currently Not yet recruiting. The study focuses on Autism Spectrum Disorder. Target enrollment is 50 participants.

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NCT06413316
Not yet recruiting
Trial Details
ClinicalTrials.gov โ€ข NCT06413316
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ABC-CT Pre-School Feasibility Study
Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study

Study Focus

Autism Spectrum Disorder

Observational

Sponsor & Location

Yale University

Los Angeles,New Haven,Boston,Durham,Seattle, United States of America

Timeline & Enrollment

N/A

Aug 01, 2024

Jun 30, 2025

50 participants

Primary Outcome

N170 Latency to Upright Human Faces,N170 Latency to Upright Human Faces,Oculomotor Index of Gaze to Human Faces (OMI),Oculomotor Index of Gaze to Human Faces (OMI)

Summary

This is a multicenter study that aims to determine whether the EEG and ET experiments studied
 in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with
 3-5-year-old children and to determine the viability of these measures as potential
 biomarkers in 3-5-year-old children with ASD. 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 advance the long term objective of
 developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility
 study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old.

ICD-10 Classifications

Childhood autism
Atypical autism
Asperger syndrome
Neurotic disorder, unspecified
Mental and behavioural disorders

Data Source

ClinicalTrials.gov

NCT06413316

Non-Device Trial