Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
研究概览
简要总结
Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system.
The primary objective of this study is to investigate the cerebral functional alterations in the serotoninergic system in patients with Parkinson's disease and impulse control disorders using Positron Emission Tomography with highly specific radiotracers of serotonin transporter (SERT) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and of serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using [18 Fluorine]-altanserin ([18F]-altanserin), in comparison to patients with Parkinson's disease without impulse control disorders and healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 Patients with Parkinson's disease and impulse control disorders
- •Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease
- •Patients aged ≥ 30 and ≤ 80 years old
- •Patients presenting currently with impulse control disorders or having presented with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2 for one or more of the following items: eating behavior; compulsive buying; pathological gambling; hypersexuality) , following the diagnosis of Parkinson's disease
- •Patients able to sign the consent document and willing to participate in all aspects of the study
- •Patients with Parkinson's disease and without impulse control disorders
- •Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease
- •Patients aged ≥ 30 and ≤ 80 years old
- •Patients not currently presenting with impulse control disorders and other hyperdopaminergic behaviors and not having ever presented with impulse control disorders
- •Patients able to sign a consent document and willing to participate in all aspects of the study
- •Group 2 : Healthy volunteers
- •Subjects aged ≥ 30 and ≤ 80 years old
- •Subjects not currently presenting with impulse control disorders or hyperdopaminergic behaviors and not having ever presented with impulse control disorders
- •Subjects able to sign a consent document and willing to participate in all aspects of the study
排除标准
- •Patients with Parkinson's disease and impulse control disorders
- •Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- •Patients not able to perform Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI)
- •Patients presenting with other severe medical condition or other parkinsonian syndrome
- •Patients treated with Deep Brain Stimulation or levodopa pump
- •Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- •Patients presenting with substance dependence, except for tobacco
- •Patients with Body Mass Index ≥ 35kilogram/meters2 (kg/m2)
- •Patients with Parkinson's disease and without impulse control disorders
- •Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- •Patients not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
- •Patients presenting with other severe medical condition or other parkinsonian syndrome
- •Patients treated with Deep Brain Stimulationor levodopa pump
- •Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- •Patients presenting with substance dependence, except for tobacco
- •Patients with Body Mass Index ≥35kg/m2
- •Group 2 : Healthy volunteers
- •Subjects with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- •Subjects not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
- •Subjects presenting with neurologic, psychiatric or other severe medical condition
- •Subjects treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- •Subjects presenting with substance dependence, except for tobacco
- •Subjects with Body Mass Index ≥35kg/m2
研究组 & 干预措施
Parkinson's Disease patients
All study participants undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). [11C] -DASB is a highly specific PET radiotracer which binds to the serotonin transporter (SERT).
[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor.
干预措施: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin) (Drug)
Imaging of healthy volunteers
All healthy volunteers undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [18F]-altanserin.
[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor.
干预措施: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin) (Drug)
结局指标
主要结局
Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
时间窗: 2-3 days
Between-group difference of binding potential of \[18 Fluorine\]-altanserin (\[18F\]-altanserin) and \[11 Carbon\]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile (\[11C\]-DASB) (\[11C\]-DASB)
次要结局
- Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)(2-3 days)
- Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS)(2-3 days)
- Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale)(2-3 days)
- Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(2-3 days)
- Beck Depression Inventory II (BDI-II)(2-3 days)
- Starkstein Apathy Scale (SAS)(2-3 days)
- State-Trait Anxiety Inventory -Y (STAI-Y)(2-3 days)
- Snaith-Hamilton Pleasure Scale (SHAPS)(2-3 days)
- Temporal Experience of Pleasure Scale (TEPS)(2-3 days)
- Stop Signal Reaction Time (SSRT)(2-3 days)
- Discounting rate(2-3 days)
- Proportion of premature responses(2-3 days)
- Polymorphism rs6313 (or T102C) of the serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor(2-3 days)
- Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT)(2-3 days)
- Magnetic Resonance Imaging metrics: anatomical imaging(2-3 days)
- Magnetic Resonance Imaging metrics: Diffusion Weighted imaging(2-3 days)
- Magnetic Resonance Imaging metrics: Resting State Functional Imaging(2-3 days)