NCT04322734 Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
| NCT ID | NCT04322734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southwest Autism Research & Resource Center |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-12-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting. There is no cost for visits or study-related exams.
Eligibility Criteria
Inclusion Criteria (ASD): 1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and/or a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening. 2. 0 years through 17 years 11 months of age Inclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric) 1\. 0 years to 17 years 11 months of age Exclusion Criteria (All): 1. History of a significant adverse reaction to a prior blood draw 2. In females of reproductive age, pregnancy or plans to become pregnant 3. Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.
Contact & Investigator
Richard E Frye, MD, PhD
STUDY DIRECTOR
Autism Discovery & Treatment Foundation
Frequently Asked Questions
Who can join the NCT04322734 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04322734 currently recruiting?
Yes, NCT04322734 is actively recruiting participants. Contact the research team at DrFrye@AutismDiscovery.org for enrollment information.
Where is the NCT04322734 trial being conducted?
This trial is being conducted at Phoenix, United States, Brooklyn, United States.
Who is sponsoring the NCT04322734 clinical trial?
NCT04322734 is sponsored by Southwest Autism Research & Resource Center. The principal investigator is Richard E Frye, MD, PhD at Autism Discovery & Treatment Foundation. The trial plans to enroll 500 participants.