GALIG Gene Expression in Parkinson's Disease (GALIGPARK)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring parkinson, alpha-synuclein, GALIG, quantitative PCR (polymerase chain reaction)
Eligibility Criteria
Inclusion Criteria:
- Patients with Parkinson's Disease according to the criteria of the UKPDBB (UK Parkinson's disease brain bank).
Exclusion Criteria:
- Insane patient arriving without a third party.
- Patient with Parkinson's disease arising from another etiology.
Sites / Locations
- CHR d'ORLEANS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Parkinson's disease patients
Arm Description
blood sampling
Outcomes
Primary Outcome Measures
RNA (ribonucleic acid) assay of GALIG gene
Only one assessment in the study
RNA (ribonucleic acid) assay of SNCA genes
Only one assessment in the study
Secondary Outcome Measures
Full Information
NCT ID
NCT02923297
First Posted
October 3, 2016
Last Updated
August 31, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
National Scientific Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT02923297
Brief Title
GALIG Gene Expression in Parkinson's Disease
Acronym
GALIGPARK
Official Title
GALIG Gene Expression in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
National Scientific Research Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements), and non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates in the brainstem and extends progressively through the entire cortex. The processes leading to cell death are poorly understood. Pathological cells exhibit abnormal deposits, called Lewy bodies, which contain numerous proteins. A major constituent of these protein deposits is alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular Biophysics of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein interacts with Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin could thus be a factor regulating α-synuclein activity or aggregation. It is postulated that the level of expression of the GALIG gene is different in Parkinson's disease patients compared with control subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson, alpha-synuclein, GALIG, quantitative PCR (polymerase chain reaction)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's disease patients
Arm Type
Other
Arm Description
blood sampling
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
blood sampling for determine and compare the expression patterns of GALIG gene
Primary Outcome Measure Information:
Title
RNA (ribonucleic acid) assay of GALIG gene
Description
Only one assessment in the study
Time Frame
Day 0
Title
RNA (ribonucleic acid) assay of SNCA genes
Description
Only one assessment in the study
Time Frame
Day 0
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Parkinson's Disease according to the criteria of the UKPDBB (UK Parkinson's disease brain bank).
Exclusion Criteria:
Insane patient arriving without a third party.
Patient with Parkinson's disease arising from another etiology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan OZSANCAK, Ph
Organizational Affiliation
CHR d'ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26483988
Citation
Alieva AKh, Filatova EV, Karabanov AV, Illarioshkin SN, Slominsky PA, Shadrina MI. Potential Biomarkers of the Earliest Clinical Stages of Parkinson's Disease. Parkinsons Dis. 2015;2015:294396. doi: 10.1155/2015/294396. Epub 2015 Sep 21.
Results Reference
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PubMed Identifier
27322389
Citation
Pinho R, Guedes LC, Soreq L, Lobo PP, Mestre T, Coelho M, Rosa MM, Goncalves N, Wales P, Mendes T, Gerhardt E, Fahlbusch C, Bonifati V, Bonin M, Miltenberger-Miltenyi G, Borovecki F, Soreq H, Ferreira JJ, F Outeiro T. Gene Expression Differences in Peripheral Blood of Parkinson's Disease Patients with Distinct Progression Profiles. PLoS One. 2016 Jun 20;11(6):e0157852. doi: 10.1371/journal.pone.0157852. eCollection 2016. Erratum In: PLoS One. 2017 Dec 28;12 (12 ):e0190552.
Results Reference
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PubMed Identifier
17215369
Citation
Scherzer CR, Eklund AC, Morse LJ, Liao Z, Locascio JJ, Fefer D, Schwarzschild MA, Schlossmacher MG, Hauser MA, Vance JM, Sudarsky LR, Standaert DG, Growdon JH, Jensen RV, Gullans SR. Molecular markers of early Parkinson's disease based on gene expression in blood. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):955-60. doi: 10.1073/pnas.0610204104. Epub 2007 Jan 10.
Results Reference
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GALIG Gene Expression in Parkinson's Disease
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