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Compensatory Mechanisms in Parkinson Disease (PD) (CompensationPD)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson, serotonin, dopamine, non motor, progression, PET

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients

  • 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)
  • For women of childbearing age a pregnancy test and a contraceptive method will be required
  • Informed consent sign

Exclusion Criteria:

Patients

  • 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).
  • Having participated to a PET or SPECT study in the last 12 months
  • Pregnancy
  • Severe concomitant disease

Sites / Locations

  • Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET

Arm Description

Outcomes

Primary Outcome Measures

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

Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution
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. The neuropsychiatric manifestations studied are : hypo and hyperdopaminergic signs : ECMP scale Apathy using LARS scale Anxiety using BAI scale Depression using BDI scale (Beck Depression Inventory) Affective well-being and asthenia using visual analogic scales of Norris MATHYS scale Global cognitive scale : MATTIS Food behavior using TFEQ scale Personality : TCI-R scale Impulsivity by UPPS scale
Role of dopaminergic and serotoninergic lesions in fatigue
: 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. Fatigue will be assessed using the PDFS-16 scale
Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life
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. Fatigue will be assessed using the PDQ39 (Parkinson's Disease Questionnaire) scale

Full Information

First Posted
January 13, 2014
Last Updated
September 18, 2015
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02038608
Brief Title
Compensatory Mechanisms in Parkinson Disease (PD)
Acronym
CompensationPD
Official Title
Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson, serotonin, dopamine, non motor, progression, PET

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET
Primary Outcome Measure Information:
Title
Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
Description
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.
Time Frame
This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Secondary Outcome Measure Information:
Title
Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution
Description
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. The neuropsychiatric manifestations studied are : hypo and hyperdopaminergic signs : ECMP scale Apathy using LARS scale Anxiety using BAI scale Depression using BDI scale (Beck Depression Inventory) Affective well-being and asthenia using visual analogic scales of Norris MATHYS scale Global cognitive scale : MATTIS Food behavior using TFEQ scale Personality : TCI-R scale Impulsivity by UPPS scale
Time Frame
These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Title
Role of dopaminergic and serotoninergic lesions in fatigue
Description
: 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. Fatigue will be assessed using the PDFS-16 scale
Time Frame
This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Title
Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life
Description
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. Fatigue will be assessed using the PDQ39 (Parkinson's Disease Questionnaire) scale
Time Frame
These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 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) For women of childbearing age a pregnancy test and a contraceptive method will be required Informed consent sign Exclusion Criteria: Patients 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). Having participated to a PET or SPECT study in the last 12 months Pregnancy Severe concomitant disease
Facility Information:
Facility Name
Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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Compensatory Mechanisms in Parkinson Disease (PD)

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