Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03156647
Acronym
PARKSYN
Enrollment
80
Registered
2017-05-17
Start date
2017-03-01
Completion date
2020-07-16
Last updated
2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Parkinsonian Disorders

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.

Interventions

DIAGNOSTIC_TESTLevel of alpha-synuclein

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groupsDay 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 groupsDay 0
Creation of a biobank with remaining samplesDay 0saliva samples
UPDRS II-III-IV scoreDay 0
UDysRs scoreDay 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
akathisiaDay 0
questionnaire on non-motor symptoms in Parkinson diseaseDay 0PD-NMS
neuro-psychological evaluationDay 0BREF+MOCO score
GDS scoreDay 0
interogation to determine extent of motor and non-motor clinical markers to differentiate the two groupsDay 0
character of parkinsonian syndromeDay 0symmetrical or asymmetrical

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026