- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923297
GALIG Gene Expression in Parkinson's Disease (GALIGPARK)
August 31, 2020 updated by: Centre Hospitalier Régional d'Orléans
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Orleans, France, 45067
- CHR d'Orléans
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Parkinson's disease patients
blood sampling
|
blood sampling for determine and compare the expression patterns of GALIG gene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RNA (ribonucleic acid) assay of GALIG gene
Time Frame: Day 0
|
Only one assessment in the study
|
Day 0
|
RNA (ribonucleic acid) assay of SNCA genes
Time Frame: Day 0
|
Only one assessment in the study
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Canan OZSANCAK, Ph, CHR d'Orléans
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
June 30, 2015
Study Completion (Actual)
June 30, 2015
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2014-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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