Observational Study on Metabolic-Immune Biomarkers in Neurological and Neurodevelopmental Disorders
This study is looking at how mitochondria (the "powerhouses" of our cells) and the immune system are connected to conditions like Autism Spectrum Disorder (ASD), epilepsy, brain tumors, and psychiatric disorders. Researchers want to understand how problems with mitochondria, specifically a process called apoptosis (programmed cell death), might contribute to these conditions. They will measure something called "Mitochondrial Reserve Capacity" using a special analyzer to see how well mitochondria are working. This study is currently recruiting up to 500 participants, from newborns to 18 years old, who have been diagnosed with ASD or other neurological/neurodevelopmental conditions. There is no cost for study visits or related exams.
- Study design
- This is an observational study with a planned enrollment of 500 participants. It is not testing a specific intervention or drug.
- What's involved
- You would have up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may also be collected.
- Compensation
- There is no cost for visits or study-related exams.
- Follow-up
- Mitochondrial Reserve Capacity will be measured for up to one year.
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Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Richard E Frye, MD, PhD · STUDY_DIRECTOR · Autism Discovery & Treatment Foundation
Who to contact
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What this trial measures
- Mitochondrial Reserve Capacity measured using the Seahorse XR Flux AnalyzerUp to one year
Children with ASD will be differentiated from all other cohorts and have a specific pattern of mitochondrial dysfunction that will be different from and comparable to other groups of children in the study (e.g. mitochondrial disease without autism, typically developing, autism with mitochondrial disease, and developmental delay). It is hypothesized that these children will have a more pronounced delay in their development and will have a higher probability for poor developmental and behavioral outcomes. This will be evaluated using a Seahorse XR flux analyzer to generate a maximal reserve capacity value.