Identifying Biomarkers in Alzheimer's Disease

Alzheimer Disease Clinical Trial

— SEEDS  

Official title:

Identifying Biomarkers in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655650
• Other study ID #: SEEDS
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Neuro-Degenerative Disease
• Neurodegenerative Diseases

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