Biomarker assay for use in monitoring autism

a biomarker and autism technology, applied in the field of biomarker assay for use in monitoring autism spectrum disorders, can solve the problems of not helping in the identification of specific neurobiological pathways underlying disease, difficulty in encompassing genetic and phenotypic heterogeneity, and worsening symptoms

Pending Publication Date: 2020-10-15
STALICLA SA
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  • Abstract
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  • Application Information

AI Technical Summary

Benefits of technology

[0016]diagnosing ASD phenotype 1 if the protein kinase A levels measured in the samp

Problems solved by technology

. . ) or comorbidities such as epilepsia can also result in a worsening of symptoms.
However, there is a growing recognition by the scientific community that the behavioral based DSM-5 diagnosis of ASD does not allow for reasonable classification in terms of molecular and genetic alterations, but rather serves as a behavior based umbrella term for a large group of disorders with different etiology.
However, these

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example

[0057]Serum samples from three patients with ASD (diagnosed based on DSM-5 criteria) were collected at two different points. The first round of serum samples was collected prior to treatment and represented baseline values prior to treatment. The second round of serum samples were collected after 1 month of treatment, wherein ibudilast at a total dosage of 0.6 mg / kg 3 times / day was administered in conjunction with bumetanide at a total daily dosage of 0.08 mg / kg administered in two daily intakes.

[0058]Protein kinase A levels of serum samples were measured using the MESACUP Protein Kinase Assay Kit (Medical & Biological laboratories CO., LTD) The assay was conducted according to the specification provided by the manufacturer.

[0059]Three patients were classified as ASD Phenotype 1 is they showed:[0060]at least 1 mandatory characteristics:[0061]enlarged head size versus control population characterized by at least one standard deviations above the mean head circumference at 24 months a...

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PUM

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Abstract

The present invention relates to protein kinase A (PKA) for use in diagnosing autism spectrum disorder (ASD) phenotype 1 in an ASD patient wherein PKA levels are measured in a sample of the patient and wherein ASD phenotype 1 is diagnosed if the measured levels are lower than PKA levels in an age and sex-matched control sample. Additionally, the present invention relates to PKA for use in monitoring variation in ASD severity in an ASD patient, wherein PKA levels are measured in a sample of the patient and an increase in ASD severity is characterized by a decrease of PKA levels compared to PKA levels measured in previous samples of the patient. The present invention also relates to PKA for use in monitoring efficacy of an ASD treatment in an ASD phenotype 1 patient, wherein PKA levels are measured in a sample of the patient and wherein a positive response to the ASD treatment is characterized by an increase of PKA levels in comparison to baseline PKA levels of the patient prior to treatment. Furthermore, the present invention is directed to methods of diagnosing ASD phenotype 1 as well as kits comprising means to measure PKA levels.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a biomarker assay for use in monitoring autism spectrum disorders (ASD), in particular ASD phenotype 1. Furthermore, the assay of the invention is also useful for diagnosing ASD phenotype 1.BACKGROUND OF THE INVENTION[0002]The cAMP-dependent protein kinase (PKA) is activated by the binding of cAMP to the regulatory subunit (R), of the molecule and results in the release of the active catalytic kinase subunit (C). Most of the effects of cAMP in eukaryotic systems are the result of phosphorylation of proteins at serine or threonine residues by PKA. There are several isoforms of both subunits of PKA. PKA is localized subcellularly by binding to multidomain scaffolding proteins known as AKAPs which bind to the R subunits of the holoenzyme (Pearce, L. R., D. Komander, and D. R. Alessi, The nuts and bolts of AGC protein kinases. Nat Rev Mol Cell Biol, 2010. 11 (1): p. 9-22). PKA plays a key role in neurodevelopment.[0003]Autism ...

Claims

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Application Information

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IPC IPC(8): C12Q1/48
CPCC12Q1/485G01N33/6893G01N2333/912G01N2800/28G01N2800/30G01N2800/38
Inventor DURHAM, LYNN
Owner STALICLA SA
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