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

Overview

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.

Full Title of Study: “Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 16, 2020

Interventions

  • Diagnostic Test: Level of alpha-synuclein
    • Test of levels of total and ratio total:oligomeric in saliva

Arms, Groups and Cohorts

  • idiopathic Parkinson disease
  • iatrogenic parkinsonian syndrome
  • healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: Day 0

Secondary Measures

  • 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.
    • Time Frame: Day 0
  • Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups
    • Time Frame: 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
    • Time Frame: Day 0
  • Creation of a biobank with remaining samples
    • Time Frame: Day 0
    • saliva samples
  • UPDRS II-III-IV score
    • Time Frame: Day 0
  • UDysRs score
    • Time Frame: Day 0
  • character of parkinsonian syndrome
    • Time Frame: Day 0
    • symmetrical or asymmetrical
  • akathisia
    • Time Frame: Day 0
  • questionnaire on non-motor symptoms in Parkinson disease
    • Time Frame: Day 0
    • PD-NMS
  • neuro-psychological evaluation
    • Time Frame: Day 0
    • BREF+MOCO score
  • GDS score
    • Time Frame: Day 0
  • interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups
    • Time Frame: Day 0

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Giovanni Castelnovo, MD, Principal Investigator, CHU Nimes

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