Phosphoproteomic Profile of Children With Down Syndrome
Key facts
- Who runs it
- Perha Pharmaceuticals
- Where
- France9 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 60 people enrolled
- Started
- 18 Mar 2024
- Ended
- 16 Apr 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Blood sample
- Record updated
- 25 April 2025
Who can take part
- Age
- 6 years to 12 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Clinical diagnosis of free and homogeneous trisomy 21,
- Body mass index (BMI): 15-25,
- Able to understand the study based on the pictorial information leaflet and give agreement/assent to participate,
- Parent present on the day of the visit to validate their child's consent/assent, if applicable
Who cannot take part
- Anti-inflammatory treatments (NSAIDs, local or systemic corticosteroids)
- Celiac disease,
- Autoimmune dysthyroidism,
- Type I autoimmune diabetes,
- Other autoimmune diseases,
- History of infantile spasms,
- Autism spectrum disorders,
- Epilepsy,
- Central nervous system infections,
- Alopecia,
- Current infectious pathology,
- Leukemia not in remission,
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.
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Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome.
The 2 groups in the trial
- Children with Down Syndrome
30 boys with Down Syndrome, between 6 and 12 years old, coming for a routine car consultation during which blood sampling is scheduled (6 different care dedicated centers).
Treatment: Blood sample
- Children without genetic abnormality
30 boys without genetic abnormality, between 6 and 12 years old, coming to an analysis laboratory for a blood test (3 different laboratories)
Treatment: Blood sample
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploratory Phosphoproteomic Study to Discover DYRK1A-Dependent Blood Biomarkers in TriSomy 21 Carriers
- Record updated
- 25 April 2025