Compensatory Mechanisms in Parkinson Disease (PD)

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: PET

• Registration Number: NCT02038608
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Study Start: 2014-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET	PET	-

Primary Outcome Measures

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

Name	Time	Method
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).	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	This will be determined 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.; Fatigue will be assessed using the PDFS-16 scale
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).	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

Trial Locations

Locations (1)

Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France