PARKSYN: Alpha-synuclein Level in Saliva to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
idiopathic Parkinson disease
|
Diagnostic Test: Level of alpha-synuclein
Test of levels of total and ratio total:oligomeric in saliva
|
iatrogenic parkinsonian syndrome
|
Diagnostic Test: Level of alpha-synuclein
Test of levels of total and ratio total:oligomeric in saliva
|
healthy volunteers
|
Diagnostic Test: Level of alpha-synuclein
Test of levels of total and ratio total:oligomeric in saliva
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- UPDRS II-III-IV score [Day 0]
- UDysRs score [Day 0]
- character of parkinsonian syndrome [Day 0]
symmetrical or asymmetrical
- akathisia [Day 0]
- questionnaire on non-motor symptoms in Parkinson disease [Day 0]
PD-NMS
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria
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The patient must have given their free and informed consent and signed the consent form
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The patient must be insured or the beneficiary of an insurance policy
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The patient is less than 55 years old
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For patients with acquired parkinsonian syndrome (UKPDSBB criteria) currently at HOEHN and YAHR stage ≤3:
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For patients recruited via a psychiatrist: after anti-dopamine treatment
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For patients recruited via a neurologist: having a recent diagnosis (≤2 years) of Parkinson disease
Exclusion Criteria:
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The subject is participating in another study
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The subject is in an exclusion period determined by a previous study
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The patients is under judicial protection
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The subject or their representative refused to sign the consent form
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It proves impossible to give the subject or their representative clear information.
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Patients with atypical degenerative parkinsonian syndrome
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Patients with vascular, post-traumatic, metabolic, toxic or genetic parkinsonian syndrome
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Appearance of parkinsonian syndrome prior to treatment with anti-dopamine
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Injection of botulinum toxin into the salivary glands
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Contra-indication on DAT-scan (unbalanced dysthyroidism, allergy, treatment with bupropion or amphetaminergics)
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Poor oral health (polyposis, gingivostomatitis) observed during the odontologist visit
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Patients not taking anti-psychotics with parkinsonian syndrome and normal DAT-scan
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hôpital Gui de Chauliac | Montpellier | France | 34000 | |
2 | Hôpital St Eloi | Montpellier | France | 34000 | |
3 | CHU Nimes | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Giovanni Castelnovo, MD, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LOCAL/2016/GC-01bis