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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Parkinsonian Disorders
Parkinson Disease

Treatments

Diagnostic Test: Level of alpha-synuclein

Study type

Observational

Funder types

Other

Identifiers

NCT03156647
LOCAL/2016/GC-01bis

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

80 participants in 3 patient groups

idiopathic Parkinson disease
Treatment:
Diagnostic Test: Level of alpha-synuclein
iatrogenic parkinsonian syndrome
Treatment:
Diagnostic Test: Level of alpha-synuclein
healthy volunteers
Treatment:
Diagnostic Test: Level of alpha-synuclein

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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