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Multimodal Biomarkers for Diagnosis and Prognosis in VCI (VCI)

2020年10月26日 更新者:National Taiwan University Hospital

Multimodal Biomarkers for Diagnosis and Prognosis in Vascular Cognitive Impairment

We will try to

  1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
  2. understand more on the pathophysiology of VCI.

研究概览

地位

招聘中

详细说明

Background and objectives Owing to the aging problem, cognitive impairment has been a worldwide health issue. Vascular cognitive impairment (VCI) and Alzheimer's disease (AD) are the two most common causes. It has been reported that VCI and AD share many common risk factors. MRI is essential in assessing the extent, location and type of vascular lesions. Amyloid PET has been used in detecting cerebral amyloid burden non-invasively since 2004. There are only small number of studies using amyloid PET in VCI and the results are still controversial. In the current proposal, we will investigate

  1. the correlation of clinical risk factors, ApoE genotype, various MRI markers, and amyloid PET expression
  2. assess the influence of ApoE genotype on different biomarkers, including MRI markers, amyloid retention, and plasma Aβ40 and Aβ42 levels
  3. the potential of amyloid PET as a prognostic factor for VCI patients.

Materials and methods This study will be conducted in National Taiwan University Hospital and Bei-Hu Branch Hospital. Sixty clinical diagnosed VCI, 30 AD patients and 30 normal subjects will be enrolled in this 3-year prospective study. We will collect vascular risk factors, neuropsychological tests, 10 cc venous blood for plasma Aβ40, Aβ42, total tau and phosphorylated level measurement by IMR assay, ApoE genotype, brain MRI, and amyloid PET of each patient and control subject. All the data will be analyzed together.

Expected Results We will try to

  1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
  2. understand more on the pathophysiology of VCI.

研究类型

介入性

注册 (预期的)

120

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾、100
        • 招聘中
        • National Taiwan Univeristy Hospital
        • 接触:
          • Yen Ruoh Fang, MD, PhD
          • 电话号码:65581 886-2-23123456
          • 邮箱:rfyen@ntu.edu.tw

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 99年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

-

I. Vascular cognitive impairment patients:

  1. Age older than 20 years.
  2. Clinical diagnosis:

    1. At least one obstacle to executive function, attention, memory, language and visual space function.
    2. Affected activities of daily living.
    3. Brain MRI showing cerebrovascular disease.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

II. Alzheimer's disease (AD) patients:

  1. Age older than 20 years.
  2. Clinical diagnosis:

    1. Amnesia or non-amnesia (language, visual space, executive ability) performance.
    2. Affected activities of daily living.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

III. Normal controls:

  1. Age older than 20 years.
  2. No neurological or psychiatric history.
  3. Patient agrees to participate in the study and is willing to receive 11C-PiB PET.

Exclusion Criteria:

-

I. Vascular cognitive impairment patients:

  1. Have other illnesses, including people with drug / alcohol abuse / addictivity within three months.
  2. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  3. Pregnant woman or intends to be pregnant in the near future.
  4. Patient who is breast feeding or intends to.
  5. Allergic to 11C-PiB, or with severe drug allergy history.
  6. Patient or the family refuses to participate in the study.

II. Alzheimer's disease (AD) patients:

  1. Have other illnesses, including:

    1. Cognitive disorders caused by cerebrovascular diseases (the decline in cognitive function is closely related to the time of stroke, multiple large-scale necrosis, and severe white matter lesions).
    2. The main manifestation of dementia is Lewy body dementia
    3. Symptoms are behavioral variation of frontotemporal dementia.
    4. The symptoms are obviously semantic progressive aphasia.
    5. Symptoms are not fluent in primary progressive aphasia.
    6. Other comorbidities that affect cognitive function (including other active neurological diseases, or non-neurological diseases but the disease or the treatment used will affect cognitive function)
  2. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  3. Pregnant woman or intends to be pregnant in the near future.
  4. Patient who is breast feeding or intends to.
  5. Allergic to 11C-PiB, or with severe drug allergy history.
  6. Patient or the family refuses to participate in the study.

III. Normal controls:

  1. Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
  2. Pregnant woman or intends to be pregnant in the near future.
  3. Patient who is breast feeding or intends to.
  4. Allergic to 11C-PiB, or with severe drug allergy history.
  5. Patient or the family refuses to participate in the study.
  6. high risk as assessed by a doctor.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:淀粉样PET、T807 PET
正电子断层扫描
Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PET成像
大体时间:3天内
PET 数据将使用有序集期望最大化进行重建,针对衰减进行校正,并且将评估每个帧以验证足够的计数统计数据和头部运动的缺失。
3天内

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月3日

初级完成 (预期的)

2023年7月31日

研究完成 (预期的)

2023年7月31日

研究注册日期

首次提交

2020年10月21日

首先提交符合 QC 标准的

2020年10月26日

首次发布 (实际的)

2020年10月27日

研究记录更新

最后更新发布 (实际的)

2020年10月27日

上次提交的符合 QC 标准的更新

2020年10月26日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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