Compensatory Mechanisms in Parkinson Disease (PD)

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038608
• Other study ID #: 2012.722
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: September 18, 2015
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• PET

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).	No
Secondary	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	These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).	No
Secondary	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	This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).	No
Secondary	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	These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).	No