Autism Spectrum Disorder Clinical Trial
Official title:
Metabolic Autism Prediction (MAP) Study
This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or other developmental delay. Two selected sites will enroll 75 participants each with another 50 typically developing participants. Participants will receive a physical exam (including a dysmorphology evaluation), ADOS, VABS, MSEL, DSM-5, and M-CHAT assessments, and receive a diagnosis. A fasting blood draw is required, consisting of 2 mL vacutainer tubes (max 4 mL). Sites must process blood according to sponsor requirements (outlined in the Sponsor's Laboratory Manual). Certain metabolite levels in the blood will be used for diagnostic screening test development.
The primary objective is to conduct a double-blind, proof-of-concept, two-site, prospective study of 200 children aged 18-60 months that have been referred for an ASD evaluation by a physician to assess the feasibility of a blood test that measures a set of blood plasma metabolites and the classification algorithm developed thereof to predict the risk of ASD. The secondary objective is to collect additional information for sub-classification of participant cohorts including Vineland Adaptive Behavior Scale (VABS) and Mullen Scale of Early Learning (MSEL) as well as any comorbidities that may correlate with blood test scores. ;
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