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

Completed

• Conditions: Parkinson Disease; Parkinsonian Disorders
• Interventions: Diagnostic Test: Level of alpha-synuclein

• Registration Number: NCT03156647
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Primary Completion: 2020-07-16
• Study Completion: 2020-07-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
idiopathic Parkinson disease	Level of alpha-synuclein	-
iatrogenic parkinsonian syndrome	Level of alpha-synuclein	-
healthy volunteers	Level of alpha-synuclein	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
questionnaire on non-motor symptoms in Parkinson disease	Day 0	PD-NMS
UPDRS II-III-IV score	Day 0
UDysRs score	Day 0
character of parkinsonian syndrome	Day 0	symmetrical or asymmetrical
akathisia	Day 0
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	saliva samples
neuro-psychological evaluation	Day 0	BREF+MOCO score
GDS score	Day 0
interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups	Day 0

Trial Locations

Locations (3)

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital St Eloi; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France