Parkinson DiseaseGeneparkNCT00465790
Research of Biomarkers in Parkinson Disease
An observational study of Parkinson Disease and Multiple System Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- How many people
- 219 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Oct 2007to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease and related
Who may be able to join
- Diagnosis of Parkinson's disease
- Ability to understand the aim of the study
- Ability to sign the consent form
Who cannot join
- Non ability to understand the aim of the study
- Non ability to sign the consent form
- To be over 18
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
University of Lübeck and Neuroimage Nord
Lübeck
University Hospital Tübingen
Tübingen
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Huntington Disease, Dystonia, Diffuse Lewy Body Disease
- Keywords
- biomarkers, neuroimaging, genetics, PET, Genetic and Idiopathic Parkinson, Multiple Systemic Atrophy, Huntington, Dopa Responsive Dystonia
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Huntington Disease, Dystonia, Lewy Body Disease, Dystonia, Dopa-responsive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients from the PDG network - Parkinson's Disease Genetics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment
Performance of a complete neurological clinical examination
Measured: Day 1
Genetic analysis
Blood test
Measured: Day 1
Transcryptome analysis
Blood sample
Measured: Day 1
Brain MRI scan
Morphometric and functional MRI
Measured: through study completion, an average of 3 years
PET scan
Analysis with [11C]-PE2I and [18F]-DOPA
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Borut Perterlin, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465790
- Sponsor's protocol ID
- C06-56
- Other IDs
- 2007-A00208-45
- Acronym
- Genepark
- Status last verified
- Dec 2011
- First submitted
- 23 Apr 2007
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENomic Biomarkers for PARKinson's Disease
- ClinicalTrials.gov ID
- NCT00465790
- Acronym / sponsor ID
- Genepark / C06-56
- Conditions
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Huntington Disease, Dystonia, Diffuse Lewy Body Disease
- Keywords
- biomarkers, neuroimaging, genetics, PET, Genetic and Idiopathic Parkinson, Multiple Systemic Atrophy, Huntington, Dopa Responsive Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- European Union
- Study start
- Oct 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from the PDG network - Parkinson's Disease Genetics | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease and related
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's disease
- Ability to understand the aim of the study
- Ability to sign the consent form
Key exclusion criteria (3 listed)
- Non ability to understand the aim of the study
- Non ability to sign the consent form
- To be over 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical assessment
Time frame: Day 1
Performance of a complete neurological clinical examination
Genetic analysis
Time frame: Day 1
Blood test
Transcryptome analysis
Time frame: Day 1
Blood sample
Brain MRI scan
Time frame: through study completion, an average of 3 years
Morphometric and functional MRI
PET scan
Time frame: through study completion, an average of 3 years
Analysis with [11C]-PE2I and [18F]-DOPA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Related InfoLink provided by the sponsor.
- Imaging software focusing on white matter may aid Parkinson's diagnosisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borut Perterlin, MD, PhD principal investigator
University Medical Centre Ljubljana
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Croatia, France, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.