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Clinical Trials/NCT02038608
NCT02038608
Completed
N/A

Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

Hospices Civils de Lyon1 site in 1 country49 target enrollmentDecember 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Hospices Civils de Lyon
Enrollment
49
Locations
1
Primary Endpoint
Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

Registry
clinicaltrials.gov
Start Date
December 1, 2014
End Date
July 1, 2015
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients presenting doparesponsive Parkinson's disease
  • Patient's age between 40 and 70 years old
  • Absence of other neurological or psychiatric disease
  • Absence of cognitive decline ( MATTIS \> 130)
  • For women of childbearing age a pregnancy test and a contraceptive method will be required
  • Informed consent sign
  • Healthy subjects
  • subject's age between 40 and 70 years old
  • Absence of neurological or psychiatric disease
  • Absence of cognitive decline ( MATTIS \> 130)

Exclusion Criteria

  • patient's age \< 40 years old or \> 70 years old
  • Other neurological or psychiatric disease
  • Cognitive decline (MATTIS \< 130).
  • Having participated to a PET or SPECT study in the last 12 months
  • Pregnancy
  • Severe concomitant disease
  • Healthy subjects
  • subject's age \< 40 years old or \> 70 years old
  • Neurological or psychiatric disease
  • Cognitive decline (MATTIS \< 130).

Outcomes

Primary Outcomes

Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease

Time Frame: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.

Secondary Outcomes

  • Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution(These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)
  • Role of dopaminergic and serotoninergic lesions in fatigue(This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)
  • Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life(These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)

Study Sites (1)

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