Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
研究概览
简要总结
Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting doparesponsive Parkinson's disease
- •Patient's age between 40 and 70 years old
- •Absence of other neurological or psychiatric disease
- •Absence of cognitive decline ( MATTIS > 130)
- •For women of childbearing age a pregnancy test and a contraceptive method will be required
- •Informed consent sign
- •Healthy subjects
- •subject's age between 40 and 70 years old
- •Absence of neurological or psychiatric disease
- •Absence of cognitive decline ( MATTIS > 130)
- •For women of childbearing age a pregnancy test and a contraceptive method will be required
- •Informed consent sign
排除标准
- •patient's age < 40 years old or > 70 years old
- •Other neurological or psychiatric disease
- •Cognitive decline (MATTIS < 130).
- •Having participated to a PET or SPECT study in the last 12 months
- •Pregnancy
- •Severe concomitant disease
- •Healthy subjects
- •subject's age < 40 years old or > 70 years old
- •Neurological or psychiatric disease
- •Cognitive decline (MATTIS < 130).
- •Having participated to a PET or SPECT study in the last 12 months
- •Pregnancy
- •Severe concomitant disease
结局指标
主要结局
Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
时间窗: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.
次要结局
- Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution(These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)
- Role of dopaminergic and serotoninergic lesions in fatigue(This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)
- Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life(These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).)