2022-503089-57-00招募中3 期
Exploratory study of the expression of the serotonergic 5-HT4 receptor in Parkinson's disease
Hospices Civils De Lyon, Hospices Civils De Lyon2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年8月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- the difference in binding of the radiotracer [11C]SB207145 to the 5-HT4 receptor between Parkinsonian patients and control subjects. For each subject, the specific binding of the tracer will be calculated for each voxel with respect to a reference zone (the white matter of the cerebellum).
研究概览
简要总结
The main objective is to compare the expression of the 5-HT4 receptor in patients with mild to moderate Parkinson's disease compared to age-matched healthy controls (controls)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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 (for patient only)
- •Duration of disease progression between 2 and 8 years (for patient only)
- •MoCA ≥ 20/30 (for patient only)
- •Age between ≥ 50 and ≤ 85 years old
- •if woman , postmenopausal woman
- •Affiliated to a social security scheme or similar
- •Having given their written consent to participate
- •Level of study: ≥ 6 years of schooling
- •No history of neurological or psychiatric disease (healthy volunteers only)
排除标准
- •Diagnosis other than Parkinson's disease ( for patient only)
- •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
- •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
结局指标
主要结局
the difference in binding of the radiotracer [11C]SB207145 to the 5-HT4 receptor between Parkinsonian patients and control subjects. For each subject, the specific binding of the tracer will be calculated for each voxel with respect to a reference zone (the white matter of the cerebellum).
the difference in binding of the radiotracer [11C]SB207145 to the 5-HT4 receptor between Parkinsonian patients and control subjects. For each subject, 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
- the description of the relationship between the level of expression of the tracer and the clinical scores on the scales of motor, non-motor, cognitive and psycho-behavioural symptoms.
- the description of the relationship between the expression level of the tracer and the polymorphism data.
研究者
Dr Jing XIE
Scientific
Hospices Civils De Lyon
研究点 (2)
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