Imaging Synapses With [11C] UCB-J in the Human Brain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cross-sectional differences in synaptic density between HC and SZ participants
研究概览
简要总结
The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer [11C]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by [11C]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 65 years in age
- •For SZ participants:
- •On a stable medication regimen for at least two weeks prior to testing
- •A clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- •Able to complete a PET-MR scan without the use of sedation
排除标准
- •Active substance use within three months of testing
- •Major medical neurological illness or significant head trauma
- •Pregnancy or breastfeeding
- •Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
- •Weight > 350 lbs or a large body habitus that MR scanner cannot accommodate
- •History of or current claustrophobia
- •Inability to comply with basic study requirements such as following directions and punctuality
- •For HC participants:
- •Presence of a first degree relative with a psychotic disorder
- •Lifetime diagnosis of major psychiatric illness
- •For SZ participants:
- •Unstable psychiatric symptoms at the time of testing, e.g. acute suicidality, prominent psychosis, or behavioral dyscontrol
研究组 & 干预措施
Healthy Control (HC) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
干预措施: [11C]UCB-J radiotracer (Drug)
Healthy Control (HC) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
干预措施: PET-MR (Device)
Schizophrenia (SZ) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
干预措施: [11C]UCB-J radiotracer (Drug)
Schizophrenia (SZ) Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the [11C]UCB-J radiotracer
干预措施: PET-MR (Device)
结局指标
主要结局
Cross-sectional differences in synaptic density between HC and SZ participants
时间窗: 120 minutes (scan duration)
Synaptic density will be quantified with the regional binding potential (BP_ND), a measure of \[11C\]UCB-J binding. BP_ND will be derived by using the simplified reference tissue model 2 (Wu \& Carson, 2002) and the centrum semiovale as the reference region. This method has been recently utilized by other investigators in neuropsychiatric samples (Chen et al., 2018). Both exploratory voxel-wise BP_ND and region of interest (ROI) BP_ND will be compared across groups. ROIs include the striatum, dorsolateral prefrontal cortex, hippocampus, and superior temporal cortex.
次要结局
未报告次要终点
研究者
Jong Yoon
Associate Professor of Psychiatry and Behavioral Sciences
Stanford University