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Phosphorylation of ERK1/2 in Patients With Parkinson's Disease (BIODYS (1))

U

University Hospital of Bordeaux

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Clinical variables

Study type

Observational

Funder types

Other

Identifiers

NCT01142739
CHUBX 2009/20

Details and patient eligibility

About

Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. Among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's Disease.

The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-pERK antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Consecutive eligible PD in- and outpatients selected at the university hospital of Bordeaux.
  • Non-demented patients (DSM IV) who are able to give their informed consent and who are affiliated to the social security.
  • Controls: Subjects without known neurological disorder, non-demented, able to give their informed consent and affiliated to the social security.

Exclusion criteria

  • Patients: Atypical or secondary parkinson disease.
  • Previous or current cancer or malignant haemopathy.
  • Known auto-immune disease.
  • Anti-neoplastic or immuno-modulator treatment (particularly corticosteroids). Immuno-deficient subjects.
  • Acute viral infection (within 2 weeks after resolving). Statin drug intake. Demented subject (DSMIV).
  • Controls: Same criteria as above plus any neurological disease.

Trial design

30 participants in 2 patient groups

Parkinson's Disease patient
Description:
levodopa-treated parkinson's disease (PD) patients
Treatment:
Other: Clinical variables
Other: Clinical variables
Other: Clinical variables
Non Parkinson's disease controls
Description:
Non Parkinson's disease controls
Treatment:
Other: Clinical variables
Other: Clinical variables
Other: Clinical variables

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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