Clinical trial NCT02038608: Compensatory Mechanisms in Parkinson Disease (PD)
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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson
serotonin
dopamine
non motor
progression
PET
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
timeFrame: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Secondary outcomes:
measure: Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution
timeFrame: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
measure: Role of dopaminergic and serotoninergic lesions in fatigue
timeFrame: This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
measure: Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life
timeFrame: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer
Study officials:
References: