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

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

Related Studies

• An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
  Enrolling By Invitation · Northwell Health · Great Neck, New York
• North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
  Recruiting · Columbia University · San Diego, California
• Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
  PHASE2 · Recruiting · Northwell Health · New York, New York
• Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
  PHASE1/PHASE2 · Recruiting · Northwell Health · New York, New York