Clinical trial NCT03156647: Alpha-synuclein Level in Saliva to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Official title: Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Parkinsonian Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from three centres:

Patients hospitalized in the Quissac psychiatric unit Patients followed in the CHU Nimes neurological department for idiopathic Parkinson Patients followed in the CHU Montpellier neurological department

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 0
Secondary outcomes:
measure: 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.
timeFrame: Day 0
measure: Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups
timeFrame: Day 0
measure: 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
timeFrame: Day 0
measure: Creation of a biobank with remaining samples
timeFrame: Day 0
measure: UPDRS II-III-IV score
timeFrame: Day 0
measure: UDysRs score
timeFrame: Day 0
measure: character of parkinsonian syndrome
timeFrame: Day 0
measure: akathisia
timeFrame: Day 0
measure: questionnaire on non-motor symptoms in Parkinson disease
timeFrame: Day 0
measure: neuro-psychological evaluation
timeFrame: Day 0
measure: GDS score
timeFrame: Day 0
measure: interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Montpellier
country: France
facility: Hôpital St Eloi
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Giovanni Castelnovo, MD
role: PRINCIPAL_INVESTIGATOR
References: