Parkinson Disease
Conditions
Keywords
serotonergic 5-HT4 receptor, radiotracer
Brief summary
The research aim to study in detail the motor, cognitive and affective modifications of Parkinsonian patients (compared to control subjects) at a moderate stage of the disease and to analyze by positron emission tomography (PET) imaging with the specific radioligand \[11C\]SB207145 the expression levels of this 5-HT4 receptor. At the same time, the study will monitor the impact of the 5-HTTLPR polymorphisms of Serotonin Transporter (SERT) and Brain-derived neurotrophic factor (BDNF) Val66Met on the expression of the 5-HT4 receptor in subjects.
Interventions
OTHERneuropsychological assessment
a consultation to assess cognitive and psycho-behavioral functions with questionnaires
OTHERbiological sample
10 mL intravenous whole blood collection in EDTA tube
PROCEDUREmedical imagery
Pet scan with the specific radioligand \[11C\]SB207145 and MRI
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Man or woman : Age between ≥ 50 and ≤ 85 years old * For women: postmenopausal * Affiliated to a social security scheme or similar; * Having given written consent to participate in the free and informed study. * Level of study: ≥ 6 years of schooling * only for healthy volunteer : No history of neurological or psychiatric disease * Only for patient : Having a clinically established or probable diagnosis of Parkinson's disease according to the criteria defined by the Movement Disorder Society at a Hoehn and Yahr stage ≤ 3 (in on dopa conditions) and a duration of evolution of the disease between 2 and 8 years. * Only for patient : Having a MoCA (Montreal Cognitive Assessment) ≥ 20/30.
Exclusion criteria
* Diagnosis other than Parkinson's disease ( for patient only) * Treated with specific serotonin inhibitors (SSRIs), specific noradrenaline inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and neuroleptics in the last 3 months * Use of recreational drugs interfering with the serotonergic system (ecstasy, MDMA) or opioids (cannabis, opiates) in the last 3 months or chronic use * Contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET) * Participation in the last year to a study using ionizing radiation or concomitant participation in another research project involving the human being that may interfere with the results or the conclusions of this study * Exceeding the annual amount of compensation authorized for participation in research protocols * Deprivation of liberty by judicial or administrative decision, person subject to a legal protection measure * BMI ≥ 35kg/m2 * Presence of depression (BDI-2 score ≥21), anxiety (Parkinson Anxiety Scale (PAS) score ≥14) or apathy (STARKSTEIN score ≥14) - (for healthy volunteers only) * Cognitive impairment (MOCA score ≤26) (for healthy volunteers only) * Current or past neurological or psychiatric pathology (for healthy volunteers only) * Serious and progressive medical pathology * Current or past dependence on any addictive substance according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders) criteria (alcohol, cannabis, hallucinogens, inhalants, opiates, sedatives, stimulants), except tobacco and caffeine. (for healthy volunteers only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls | During MRI procedure | difference in the tracer \[11C\]SB207145 's binding, the specific binding of the tracer will be calculated for each voxel with respect to a reference zone (the white matter of the cerebellum). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of 5-HT4 alterations related to non-motor symptoms | During MRI procedure | Relationship between the level of expression of the tracer and the clinical scores on the non-motor questionnaires |
| Description of 5-HT4 alterations related to cognitive symptoms | During MRI procedure | Relationship between the level of expression of the tracer and the clinical scores on the cognitive questionnaires |
| Description of 5-HT4 alterations related to motor symptoms | During MRI procedure | Relationship between the level of expression of the tracer and the clinical scores on the motor questionnaires |
| Description of 5-HT4 alterations related to SERT polymorphism data | During MRI procedure | Relationship between the level of expression of the tracer and SERT polymorphism data (5-HTTLPR polymorphism, evaluated as presence/absence) |
| Description of 5-HT4 alterations related to BDNF polymorphism data | During MRI procedure | Relationship between the level of expression of the tracer and BDNF polymorphism data (Val66Met rs6265 polymorphism, evaluated as presence/absence) |
| Description of 5-HT4 alterations related to psychobehavioral symptoms | During MRI procedure | Relationship between the level of expression of the tracer and the clinical scores on the psychobehavioral questionnaires |
Countries
France
Outcome results
None listed