NCT05490576Unknown1 期
Pilot Phase 1 Clinical Trial of PET Scanning in Tau Protein Deposition and Connectome Analysis in Traumatic Encephalopathy Syndrome (TES) Cohort With a Probable Chronic Traumatic Encephalopathy (CTE) Pattern of Neurodegenerative Disease
Macquarie University, Australia2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年2月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Detection of Tau protein 3R and 4R isoforms in patients who meet the Traumatic Encephalopathy Syndrome (TES) criteria, as defined by the National Institute of Neurological Disorders and Stroke.
研究概览
简要总结
This pilot study aims to assess if participants that meet the criteria for a TES diagnosis have a specific tau deposition profile on PET scanning using the PET tau binding ligand - [18F] PI-2620. It is hoped this study will highlight potential diagnostic tests of TES diagnosis, the in-life correlate of CTE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •The participant must have full capacity to understand the purpose and risks of the study to provide informed consent.
- •All participants must be between 40 to 70 years of age.
- •Must meet the Traumatic Encephalopathy Syndrome criteria as defined by the National Institute of Neurological Disorders and Stroke Consensus Diagnostic Criteria for Traumatic Encephalopathy Syndrome, Katz. D, et. al. Neurology,
- •Participants must demonstrate that they have a cognitive decline, evident by performance on neuropsychological testing.
- •Standard of care blood screening within 12 months of consent to the study to exclude other medical conditions which may cause cognitive decline, such as heavy metal toxicology.
- •A PET scan within 6 months of consent to the study that is not consistent with Alzheimer's disease.
- •Participants must consent to undertake Positron Emission Tomography (PET) with intravenous [18F] PI-2620 PET tracer ligand.
- •Participants must be able to lie still, on their back for up to 60 minutes for the scans.
- •Participants must not have any metal in their bodies e.g. pacemakers, aneurysm clips which are contraindications of MRI.
- •Participants must consent to the use of their medical records and medical history, including but not limited to pathology results, previous imaging results and neuropsychology results
排除标准
- •Participants will be excluded if they do not meet all the inclusion criteria.
- •Participants must not be diagnosed with or suspected to be suffering from any other neurodegenerative disease, or cerebral disease affecting cognition as identified by results of neuropsychological evaluation or neurologist consultation.
- •Participants will be excluded if Staff at Macquarie Medical Imaging determine that the participant is not suitable for imaging, for any reason.
- •Participants will be excluded if they have kidney and/or liver dysfunction as diagnosed by a doctor
研究组 & 干预措施
[18F] PI-2620 PET Tau Ligand Active Agent
Experimental
Participants receive dose of active agent [18F] PI-2620 PET Tau Ligand during dynamic PET scan acquisition
干预措施: [18F] PI-2620 Tau Ligand (Radiation)
结局指标
主要结局
Detection of Tau protein 3R and 4R isoforms in patients who meet the Traumatic Encephalopathy Syndrome (TES) criteria, as defined by the National Institute of Neurological Disorders and Stroke.
时间窗: 2 weeks
Participants are either Tau positive or Tau negative, determined by the PET scan
次要结局
- Detect disease anomalies on MRI which correlated with brain region tau deposition(2 weeks)
- Compare PET tau imaging PI-2620 results in TES to prior studies in Alzheimer's disease using the same ligand(2 weeks)
研究者
研究点 (2)
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