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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05655650
Other study ID # SEEDS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2030

Study information

Verified date December 2022
Source Chinese University of Hong Kong
Contact Pualine Kwan
Phone +852 26352160
Email paulinekwan@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong Hong Hong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary The score change in Hong Kong List Learn Test (HKLLT) 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
Primary The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA) 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
Primary The score change Clinical Dementia Rating (CDR) 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
Primary Amount of amyloid ß with 11C-Pittsburgh compound B Positron emission tomography imaging with 11C-Pittsburgh compound B would quantify the amount of amyloid ß. Amyloid ß is one of the biomarkers associate Alzheimer Disease Baseline
Primary Amount of amyloid tau with T807 tracer 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
Primary Amount of glucose hypometabolism 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
Primary arterial spin labeling magnetic resonance perfusion (ASL-MRP) Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects Baseline
Primary Change of Automatic Retinal Imaging 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
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