Alpha-synuclein Level in Saliva to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome (PARKSYN)

Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome

The aim of this study is to determine whether a significant reduction in the total level of alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson disease compared to patients with drug-induced parkinsonian syndrome.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Parkinsonian Disorders
• Intervention / Treatment: Diagnostic test: Level of alpha-synuclein

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Hopital Gui de Chauliac
  • Montpellier, France, 34000
    • Hôpital St Eloi
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from three centres:

Patients hospitalized in the Quissac psychiatric unit Patients followed in the CHU Nimes neurological department for idiopathic Parkinson Patients followed in the CHU Montpellier neurological department

Description

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be insured or the beneficiary of an insurance policy
• The patient is less than 55 years old

• For patients with acquired parkinsonian syndrome (UKPDSBB criteria) currently at HOEHN and YAHR stage ≤3:

  • For patients recruited via a psychiatrist: after anti-dopamine treatment
  • For patients recruited via a neurologist: having a recent diagnosis (≤2 years) of Parkinson disease

Exclusion Criteria:

• The subject is participating in another study
• The subject is in an exclusion period determined by a previous study
• The patients is under judicial protection
• The subject or their representative refused to sign the consent form
• It proves impossible to give the subject or their representative clear information.
• Patients with atypical degenerative parkinsonian syndrome
• Patients with vascular, post-traumatic, metabolic, toxic or genetic parkinsonian syndrome
• Appearance of parkinsonian syndrome prior to treatment with anti-dopamine
• Injection of botulinum toxin into the salivary glands
• Contra-indication on DAT-scan (unbalanced dysthyroidism, allergy, treatment with bupropion or amphetaminergics)
• Poor oral health (polyposis, gingivostomatitis) observed during the odontologist visit
• Patients not taking anti-psychotics with parkinsonian syndrome and normal DAT-scan

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Diagnostic test: Level of alpha-synuclein; Test of levels of total and ratio total:oligomeric in saliva
idiopathic Parkinson disease	Diagnostic test: Level of alpha-synuclein; Test of levels of total and ratio total:oligomeric in saliva
iatrogenic parkinsonian syndrome	Diagnostic test: Level of alpha-synuclein; Test of levels of total and ratio total:oligomeric in saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare saliva level of oligomeric alpha-synuclein between two groups of patients wth classical parkinsonian: patients with idiopathic Parkinson disease and patients with a acquired parkinsonian syndrome from anti-dopamine treatment.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perform the first estimation of discriminatory capacity of saliva levels of oligomeric alpha-synuclein for diagnostic differentiation between idiopathic Parkinson disease and anti-dopamine induced acquired parkinsonian syndrome.		Day 0
Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups		Day 0
Perform the first estimation of discriminatory capacity of saliva levels of total oligomeric alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein for diagnostic differentiation between two groups		Day 0
Creation of a biobank with remaining samples	saliva samples	Day 0
UPDRS II-III-IV score		Day 0
UDysRs score		Day 0
character of parkinsonian syndrome	symmetrical or asymmetrical	Day 0
akathisia		Day 0
questionnaire on non-motor symptoms in Parkinson disease	PD-NMS	Day 0
neuro-psychological evaluation	BREF+MOCO score	Day 0
GDS score		Day 0
interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups		Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Giovanni Castelnovo, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): July 16, 2020
• Study Completion (ACTUAL): July 16, 2020

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: LOCAL/2016/GC-01bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No