Status:
RECRUITING
Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
Lead Sponsor:
Southwest Autism Research & Resource Center
Collaborating Sponsors:
State University of New York - Downstate Medical Center
Conditions:
Autism Spectrum Disorder
Mitochondrial Pathology
Eligibility:
All Genders
Up to 18 years
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 ...
Detailed Description
Mitochondria are essential for a wide range of functions in almost every cell in our body. Best known for their role in adenosine triphosphate (ATP) production, mitochondria are also closely involved ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (ASD):
- 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.
- 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):
- History of a significant adverse reaction to a prior blood draw
- In females of reproductive age, pregnancy or plans to become pregnant
- Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.
Exclusion
Key Trial Info
Start Date :
December 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04322734
Start Date
December 13 2023
End Date
December 31 2028
Last Update
December 27 2024
Active Locations (2)
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1
Southwestern Research and Resource Center
Phoenix, Arizona, United States, 85016
2
State University of New York, Downstate
Brooklyn, New York, United States, 11203