NCT05916625已完成不适用
Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 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)
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 psychobehavioral symptoms(During MRI procedure)
- 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 SERT polymorphism data(During MRI procedure)
- Description of 5-HT4 alterations related to BDNF polymorphism data(During MRI procedure)
研究者
研究点 (3)
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