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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT03156647
Collaborator
(none)
80
3
40.5
26.7
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Level of alpha-synuclein

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jul 16, 2020
Actual Study Completion Date :
Jul 16, 2020

Arms and Interventions

Arm Intervention/Treatment
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

healthy volunteers

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

Outcome Measures

Primary Outcome Measures

  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. [Day 0]

Secondary Outcome Measures

  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. [Day 0]

  2. Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups [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 [Day 0]

  4. Creation of a biobank with remaining samples [Day 0]

    saliva samples

  5. UPDRS II-III-IV score [Day 0]

  6. UDysRs score [Day 0]

  7. character of parkinsonian syndrome [Day 0]

    symmetrical or asymmetrical

  8. akathisia [Day 0]

  9. questionnaire on non-motor symptoms in Parkinson disease [Day 0]

    PD-NMS

  10. neuro-psychological evaluation [Day 0]

    BREF+MOCO score

  11. GDS score [Day 0]

  12. interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Gui de Chauliac Montpellier France 34000
2 Hôpital St Eloi Montpellier France 34000
3 CHU Nimes Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Giovanni Castelnovo, MD, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT03156647
Other Study ID Numbers:
  • LOCAL/2016/GC-01bis
First Posted:
May 17, 2017
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2021