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识别阿尔茨海默病的生物标志物 (SEEDS)

2026年9月16日更新者：Vincent Mok、Chinese University of Hong Kong

Alzheimer's disease is a severe neurodegenerative disorder of the brain that is characterized by progressive loss of memory and cognitive decline. With the ageing population, AD is a major public health problem affecting nearly 35 million people worldwide with numbers projected to rise to 115.4 million by 2050. AD is the only cause of death among the top ten causes that has no prevention or cure . It is believed that novel treatment of AD needs to start early or even at the prodromal stage in order to be effective. Therefore, there is an urgent need to find accurate methods of early detection before patients with AD develop clinical dementia.

This study aims to identify biomarkers for AD in local Chinese population. this study hypothesizes blood-based proteomics, retinal imaging, ASL-MRP and tau PET can improve the accuracy and staging of AD.

研究概览

地位

招聘中

条件

详细说明

This is a cohort study. It involves baseline and 6 yearly follow ups. At baseline, all participants will go through a list of cognitive assessments, blood taking, Brain MRI scan, Brain PET scan and retinal imaging.

At the first five yearly follow ups, cognitive assessment will be performed. For the sixth yearly follow up, automatic retinal image will be performed in addition to cognitive assessment.

研究类型

观察性的

注册 (估计的)

300

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。

学习联系方式

姓名：Pualine Kwan
电话号码：+852 26352160
邮箱：paulinekwan@cuhk.edu.hk

研究联系人备份

姓名：Elyia Han
电话号码：+852 2697 5027
邮箱：elyiahan@cuhk.edu.hk

学习地点

香港
- Hong Hong
  - Hong Kong、Hong Hong、香港
    - 招聘中
    - Chinese University of Hong Kong
    - 首席研究员：
      
      Vincent Mok, MD
    - 接触：
      
      Elyia Han, Bachelor
      
      电话号码：+852 26975027
      
      邮箱：elyiahan@cuhk.edu.hk

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年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

AD subjects will be recruited from neurology cognitive disorder clinic of Prince of Wales Hospital. Age match normal control will be recruited from existing normal control studies.

描述

Inclusion Criteria:

Chinese ethnicity
[For dementia group, clinical diagnosis of "probable Alzheimer's disease" according to recommendation from the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA)

Exclusion Criteria:

Clinical diagnosis of non-AD dementia
contraindication for MRI or PET

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

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Normal cognition 75 subject without any of the following: subjective memory complaint and cognitive impairment base on cognitive assessments
Subjective Cognitive Disorder 75 subjects without cognitive impairment based on cognitive cognitive assessments but with subject memory complaint
Mild Cognitive Impairment 75 subjects with both subjective memory complaints and mild cognitive impairment base on cognitive assessments
Dementia 75 subjects with both subjective memory complaints and moderate to severe cognitive impairment base on cognitive assessments

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
The score change in Hong Kong List Learn Test (HKLLT) 大体时间：Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit	The Hong Kong List Learn Test would be administered to assess the cognitive status for all group of study subjects	Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA) 大体时间：Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit	The Montreal Cognitive Assessment Hong Kong would be administered to assess the cognitive status for all group of study subjects	Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
The score change Clinical Dementia Rating (CDR) 大体时间：Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit	The Clinical Dementia Rating would be administered to assess the cognitive status for all group of study subjects	Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
Amount of amyloid β with 11C-Pittsburgh compound B 大体时间：Baseline	Positron emission tomography imaging with 11C-Pittsburgh compound B would quantify the amount of amyloid β. Amyloid β is one of the biomarkers associate Alzheimer Disease	Baseline
Amount of amyloid tau with T807 tracer 大体时间：Baseline	Positron emission tomography imaging with T807 tracer would quantify the amount of tau protein. tau protein is one of the biomarkers associate with Alzheimer Disease	Baseline
Amount of glucose hypometabolism 大体时间：Baseline	Positron emission tomography imaging with 18F-FDG tracer would quantify the amount of glucose hypometabolism. glucose hypometabolism is one of the biomarkers associate with Alzheimer Disease	Baseline
arterial spin labeling magnetic resonance perfusion (ASL-MRP) 大体时间：Baseline	Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects	Baseline
Change of Automatic Retinal Imaging 大体时间：Baseline, 6th year follow up	There is a close anatomical correlation between both the macrovascular and the microvascular blood supply to the brain and the retina, and both vascular networks share similar vascular regulatory processes. Automatic Retinal Imaging is used to investigate microcirculations in retinal	Baseline, 6th year follow up

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。

赞助

Chinese University of Hong Kong

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)

2018年9月1日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2022年12月9日

首先提交符合 QC 标准的

2022年12月9日

首次发布 (实际的)

2022年12月19日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日