Phosphorylation of ERK1/2 in Patients With Parkinson's Disease

NCT01142739 | Completed

• 1 other identifier: CHUBX 2009/20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• ERK phosphorylation

  Distribution of variables and difference in the state of ERK phosphorylation in two contrasted groups : the dyskinetic levodopa-treated PD group and control group.

  Day 1

Secondary Outcomes (2)

• plasma and urinary dopamine in "on" and "off" state

  Day 1

• measure derivatives of morphine

  Day 1

Study Arms (2)

Parkinson's Disease patient

levodopa-treated parkinson's disease (PD) patients

Other: Clinical variables

Non Parkinson's disease controls

Non Parkinson's disease controls

Other: Clinical variables

Interventions

Clinical variables OTHER

Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV). Biological variables.

Parkinson's Disease patient

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive eligible PD in- and outpatients selected at the university hospital of bordeaux and subjects without known neurological disorder in a community sample.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Université Victor Segalen Bordeaux 2: collaborator

Study Sites (1)

CHU de Bordeaux Hôpital Haut Lévêque

Pessac, 33604, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood urine

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nathalie DAMON-PERRIERE, Dr.

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, Pr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 11, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

FR (1)