Identifying Biomarkers in Alzheimer's Disease

Recruiting

• Conditions: Neuro-Degenerative Disease; Alzheimer Disease

• Registration Number: NCT05655650
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of amyloid β with 11C-Pittsburgh compound B	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)	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)	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)	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)	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	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	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	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

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Hong, Hong Kong