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临床试验/NCT05655650
NCT05655650招募中不适用

Identifying Biomarkers in Alzheimer's Disease

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Amount of amyloid β with 11C-Pittsburgh compound B

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Amount of amyloid β with 11C-Pittsburgh compound B

时间窗: 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

arterial spin labeling magnetic resonance perfusion (ASL-MRP)

时间窗: Baseline

Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects

The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA)

时间窗: 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

The score change Clinical Dementia Rating (CDR)

时间窗: 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

The score change in Hong Kong List Learn Test (HKLLT)

时间窗: 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

Amount of amyloid tau with T807 tracer

时间窗: 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

Amount of glucose hypometabolism

时间窗: 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

Change of Automatic Retinal Imaging

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincent Mok

Professor

Chinese University of Hong Kong

研究点 (1)

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