Muscarinic M1 Receptor Availability and Cognition in Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Hippocampal M1 availability
研究概览
简要总结
This exploratory study seeks to examine M1 receptor availability in SZ patients and to relate M1 receptor availability to proximal and distal measures of cognitive performance, namely evoked ɣ oscillations in the EEG and verbal memory. Furthermore, the relationship between hippocampal [11C]EMO availability (BPND), evoked ɣ oscillations, verbal memory, and measures of illness severity will be explored.
详细描述
Converging lines of evidence from postmortem studies provide strong evidence that brain muscarinic M1 receptor deficit is present in a subset of schizophrenia (SZ) patients. M1 receptors are an important target for cognitive deficits in SZ. However, until now, it has not been possible to examine the heterogeneity of SZ with respect to M1 receptor availability in vivo. The development of a novel positron emission tomography (PET) ligand, [11C]EMO, at Yale PET Center provides a unique opportunity to, for the first time, examine in vivo brain muscarinic M1 receptor availability in SZ and, concurrently, elucidate the relationship of M1 receptors to cognitive deficits in SZ.
The investigators will compare M1 receptor availability in SZ patients and age-, gender-matched healthy controls using [11C]EMO and the High Resolution Research Tomograph (HRRT), a PET scanner with high sensitivity and resolution available for human brain imaging. This study will explore the relationship between: hippocampal [11C]EMO binding (as a measure of hippocampal M1 AChR availability), encoding-related γ power during a verbal memory task, verbal memory, gender, and serum acetylcholine level. This exploratory study will provide the necessary pilot data to conduct a larger study to fully investigate the heterogeneity of SZ with respect to M1 receptor availability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Men and women aged 18- 65 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis
- •Subjects with no metal in the body that may pose a risk during MRI scanning
- •No significant medical history, including head trauma and bleeding disorders
排除标准
- •Men and women with a history or presence of clinically significant medical conditions
- •People who suffer from claustrophobia, have MRI incompatible implants, or other contraindications for MRI and PET scans
研究组 & 干预措施
Schizophrenia or schizoaffective disorder
Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi
干预措施: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor (Drug)
Schizophrenia or schizoaffective disorder
Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi
干预措施: PET Scan (Device)
Healthy Controls
Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi
干预措施: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor (Drug)
Healthy Controls
Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi
干预措施: PET Scan (Device)
结局指标
主要结局
Hippocampal M1 availability
时间窗: 10 days
Measured by \[11C\]EMO availability (BPND)
次要结局
- verbal memory(10 days)
- evoked ɣ oscillations(10 days)
研究者
Rajiv Radhakrishnan, MD
Assistant Professor of Psychiatry
Yale University