Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Other: neuropsychological assessmentOther: biological sampleProcedure: medical imagery
- Registration Number
- NCT05916625
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pet scan with the specific radioligand [11C]SB207145 medical imagery The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires Pet scan with the specific radioligand [11C]SB207145 biological sample The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires Pet scan with the specific radioligand [11C]SB207145 neuropsychological assessment The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (2)
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
🇫🇷Lyon, France
CERMEP
🇫🇷Bron, France