MAP Autism Prediction Study

Phase

N/A

Condition

Asperger's Disorder

Williams Syndrome

Autism

Treatment

N/A

Clinical Study ID

NCT04672967

1320036

Ages 18-60
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of thefollowing criteria:

18-60 months of age
Primary language is English (this is due to the evaluation instruments being used,which are in the English language).
Suspected developmental concern and referral to the developmental center by child'sphysician
Parental informed consent to participate in the study (based on the age range of thechildren in this study, assent is being waived)
Willingness to comply with all study procedures
Not currently enrolled in another clinical trial

Exclusion

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participationin this study:

Previous diagnosis of ASD or DD
Prematurity < 34 weeks' gestation
Has a sibling already enrolled in the trial
Profound sensory deficits (e.g., hearing and vision deficits) that could interferewith the interpretation of study results
Documented current or active seizures, as defined by a clinical seizure or abnormalEEG within the past six months
Major genetic defect as determined by chromosomal microarray or other method ofgenetic detection
Currently taking any high dose (greater than recommended daily allowance) dietarysupplements
Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks ofenrollment
Diagnosis with congenital brain malformations, moderate to severe traumatic braininjury, congenital or acquired microcephaly, or infection of the central nervoussystem (e.g., meningitis, viral encephalitis)
Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
Fever (temperature > 100 degrees Fahrenheit) within the past 72 hours
Any other reason that the clinical investigator feels may place the participant at anunnecessary risk to participate

Study Design

November 03, 2021

October 31, 2022

Study Description

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.

Connect with a study center

VUMC
Nashville, Tennessee 37212
United States
Active - Recruiting

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