Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Pet scan with the specific radioligand [11C]SB207145
The following examen are added by the study :
neuropsychologic consultation PET scan MRI biological sample Questionnaires
干预措施: biological sample (Other)
Pet scan with the specific radioligand [11C]SB207145
The following examen are added by the study :
neuropsychologic consultation PET scan MRI biological sample Questionnaires
干预措施: neuropsychological assessment (Other)
Pet scan with the specific radioligand [11C]SB207145
The following examen are added by the study :
neuropsychologic consultation PET scan MRI biological sample Questionnaires
干预措施: medical imagery (Procedure)
结局指标
主要结局
Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls
时间窗: 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).
次要结局
- Description of 5-HT4 alterations related to motor symptoms(During MRI procedure)
- Description of 5-HT4 alterations related to non-motor symptoms(During MRI procedure)
- Description of 5-HT4 alterations related to cognitive symptoms(During MRI procedure)
- Description of 5-HT4 alterations related to psychobehavioral symptoms(During MRI procedure)
- Description of 5-HT4 alterations related to SERT polymorphism data(During MRI procedure)
- Description of 5-HT4 alterations related to BDNF polymorphism data(During MRI procedure)