Parkinson Disease Clinical Trial
— PARKSYNOfficial title:
Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Verified date | July 2021 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Gui de Chauliac | Montpellier | |
France | Hôpital St Eloi | Montpellier | |
France | CHU Nimes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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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