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
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
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
NCT ID
NCT02038608
First Posted
January 13, 2014
Last Updated
September 18, 2015
Sponsor
Hospices Civils de Lyon
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
Learn more about this trial
Compensatory Mechanisms in Parkinson Disease (PD)
We'll reach out to this number within 24 hrs