NCT02923297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

October 3, 2016

Last Update Submit

August 31, 2020

Conditions

Parkinson Disease

Keywords

parkinsonalpha-synucleinGALIGquantitative PCR (polymerase chain reaction)

Outcome Measures

Primary Outcomes (2)

  • RNA (ribonucleic acid) assay of GALIG gene

    Only one assessment in the study

    Day 0

  • RNA (ribonucleic acid) assay of SNCA genes

    Only one assessment in the study

    Day 0

Study Arms (1)

Parkinson's disease patients

OTHER

blood sampling

Other: Blood sampling

Interventions

Blood samplingOTHER

blood sampling for determine and compare the expression patterns of GALIG gene

Parkinson's disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Parkinson's Disease according to the criteria of the UKPDBB (UK Parkinson's disease brain bank).

You may not qualify if:

  • Insane patient arriving without a third party.
  • Patient with Parkinson's disease arising from another etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'ORLEANS

Orléans, 45067, France

Location

Related Publications (3)

  • 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.

    PMID: 26483988BACKGROUND

  • 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.

    PMID: 27322389BACKGROUND

  • 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.

    PMID: 17215369BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Canan OZSANCAK, Ph

    CHR d'ORLEANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 4, 2016

Study Start

April 1, 2015

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)