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Clinical Trials/NCT05655650
NCT05655650
Recruiting
Not Applicable

Identifying Biomarkers in Alzheimer's Disease

Chinese University of Hong Kong1 site in 1 country300 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuro-Degenerative Disease
Sponsor
Chinese University of Hong Kong
Enrollment
300
Locations
1
Primary Endpoint
Amount of amyloid β with 11C-Pittsburgh compound B
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
December 31, 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vincent Mok

Professor

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

Amount of amyloid β with 11C-Pittsburgh compound B

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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