Skip to main content
OpenTrials
Completed

NCT Number: NCT03156647

Alpha-synuclein Level in Saliva 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Gui de Chauliac, Montpellier, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Level of alpha-synuclein

Diagnostic Test

Test of levels of total and ratio total:oligomeric in saliva

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups

    Time frame: Day 0

  3. 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

  4. Creation of a biobank with remaining samples

    Time frame: Day 0

    saliva samples

  5. UPDRS II-III-IV score

    Time frame: Day 0

  6. UDysRs score

    Time frame: Day 0

  7. character of parkinsonian syndrome

    Time frame: Day 0

    symmetrical or asymmetrical

  8. akathisia

    Time frame: Day 0

  9. questionnaire on non-motor symptoms in Parkinson disease

    Time frame: Day 0

    PD-NMS

  10. neuro-psychological evaluation

    Time frame: Day 0

    BREF+MOCO score

  11. GDS score

    Time frame: Day 0

  12. interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: PARKSYN

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 17, 2017
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.