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

NCT03156647 | Completed

• 1 other identifier: LOCAL/2016/GC-01bis
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease; Parkinsonian Disorders

Outcome Measures

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.

  Day 0

Secondary Outcomes (12)

• 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

  Day 0

• UPDRS II-III-IV score

  Day 0

Study Arms (3)

idiopathic Parkinson disease

Diagnostic Test: Level of alpha-synuclein

iatrogenic parkinsonian syndrome

Diagnostic Test: Level of alpha-synuclein

healthy volunteers

Diagnostic Test: Level of alpha-synuclein

Interventions

Level of alpha-synuclein DIAGNOSTIC_TEST

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

healthy volunteers; iatrogenic parkinsonian syndrome; idiopathic Parkinson disease

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• The subject is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

Hôpital Gui de Chauliac

Montpellier, 34000, France

Location

Hôpital St Eloi

Montpellier, 34000, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Giovanni Castelnovo, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: March 1, 2017
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)