Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

Conditions

• Autism Spectrum Disorder
• Brain Tumor
• Epilepsy
• Mitochondrial Diseases
• Mitochondrial Pathology
• Psychiatric Disorder

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

First listed

Mar 26, 2020

Start date

Dec 13, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: ASD (General)
  150 children with ASD and unknown MD status
• Arm: ASD (With MD)
  50 children with ASD and confirmed MD
• Arm: ASD (No MD)
  50 children with ASD and ruled out MD
• Arm: Epilepsy
  50 children with epilepsy (primary) and no ASD
• Arm: Brain Tumor
  50 children with brain tumor (primary) and no ASD
• Arm: Psychiatric Disorder
  50 children with psychiatric disorder (primary) and no ASD, using lithium treatments
• Arm: MD (No ASD)
  50 children with MD (primary) and no ASD
• Arm: TD (With ASD Sibling)
  50 TD children with a sibling with ASD/neurodevelopmental delay
• Arm: TD (No ASD Sibling)
  50 TD children with no siblings with ASD/neurodevelopmental delay

Primary Outcome Measure

Mitochondrial Reserve Capacity measured using the Seahorse XR Flux Analyzer [ Time Frame: Up to one year ]

Central Contacts

• Richard E Frye, MD, PhD
  844-ADTFRes
  [email protected]

Locations (2)

Find similar trials in Phoenix, AZ

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