Parkinson Disease Clinical Trial
Official title:
GENomic Biomarkers for PARKinson's Disease
The main goal of the GENEPARK consortium is to employ innovative haemogenomic approaches to
determine gene expression profiles specific for genetic and idiopathic Parkinson's disease
(PD) patients. These gene expression signatures will be utilised clinically as non-invasive
diagnostic tests for PD. The sensitivity of the newly developed diagnostic test will be
determined by extensive validations on an independent cohort of PD patients, whereas the
specificity will be assessed by testing patients with atypical parkinsonisms, including
multiple system atrophy, progressive supranuclear palsy and diffuse Lewy body disease. In
order to test the specificity of the diagnostic set in other disorders that affect basal
ganglia, Huntington's disease and dopa responsive dystonia patients will be analysed. The
second objective of the proposal is to determine correlations between gene expression
signatures and different stages of PD and thus provide the basis for early diagnosis and
monitoring of disease progression. These changes in blood gene expression will be correlated
with alterations detected by neuroimaging in the brain of PD patients. Such combinations of
molecular and morphological markers of disease may ultimately facilitate the selection and
monitoring of neuroprotective therapies for PD. Finally, GENEPARK aims to develop new
bioinformatic software tools for selection of genomic biomarkers using microarray data. A
set of established computational tools will be applied and novel methods, some of them based
on mechanistic modelling of the neurodegenerative diseases, will be developed in order to
study the advantages and limitations of the different methodologies.
With special emphasis on the careful clinical selection of patients and sufficient power
regarding patient numbers, as well as extensive quality control and validation of the data,
GENEPARK aims to develop a standardised approach to development and validation of
haemogenomic biomarkers of disease.
Employ innovative haemogenomic approaches to determine gene expression signatures specific
for idiopathic Parkinson's disease (PD). There is currently no specific clinical or
laboratory diagnostic test available for PD. In GENEPARK, blood samples from patients with
genetic PD and idiopathic PD will be analysed by microarrays to identify gene expression
signatures specific for PD. The specificity of the new biomarkers for PD will be tested by
the analysis of patients with atypical parkinsonisms, including multiple system atrophy
(MSA), progressive supranuclear palsy (PSP) and diffuse Lewy body disease (DLBD), as well as
in patients with other basal ganglia disorders such as Huntington's disease (HD) and dopa
responsive dystonia (DRD). The validated gene expression signatures will be utilised to
develop a new test for diagnosis of idiopathic PD. Determine correlation between gene
expression signatures and different stages of PD.
Gene expression in presymptomatic and symptomatic patients with genetic forms of PD as well
as patients in various stages of idiopathic PD will be analysed to identify gene expression
signatures specific for various stages of the disease. It should be emphasised that since no
clinical measures are present in presymptomatic genetic PD such molecular markers could
serve as surrogate markers to monitor therapeutic efficacy of possible preventive treatments
in PD. Determine correlations between gene expression signatures and morphological evidence
of neurodegenerative process in PD brain as determined by neuroimaging. Gene expression
signatures identified in blood samples will be correlated with changes in brain as detected
by neuroimaging in PD patients. Such correlations of molecular and morphological markers of
disease will facilitate the selection of blood markers in relation to disease progression.
Moreover, molecular and morphological markers of disease progression could be utilised in
combination for monitoring the effects of new neuroprotective therapies for PD. Develop
standardised approaches to development and validation of haemogenomic biomarkers.
This objective will be achieved by the special emphasis on careful clinical selection of
patients, sufficient power regarding patient numbers, as well as extensive quality control
and validation of the data. Develop new bioinformatic software tools for selection of
genomic biomarkers using microarray data. The aim of the GENEPARK is to develop the
theoretical foundations and to build the software tools for sample classification and
selection of genomic biomarkers using microarray data. The established computational tools
and novel methods developed within the GENEPARK will be applied to the patient data to study
advantages and limitations of different methodologies.
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