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

Parkinson Disease Clinical Trial

— PARKSYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156647
• Other study ID #: LOCAL/2016/GC-01bis
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: July 16, 2020

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 16, 2020
• Est. primary completion date: July 16, 2020
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Gui de Chauliac	Montpellier
France	Hôpital St Eloi	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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