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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156647
Other study ID # LOCAL/2016/GC-01bis
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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