Identifying Biomarkers in Alzheimer's Disease (SEEDS)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Neuro-Degenerative Disease

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Pualine Kwan; Phone Number: +852 26352160; Email: paulinekwan@cuhk.edu.hk
• Study Contact Backup: Name: Elyia Han; Phone Number: +852 2697 5027; Email: elyiahan@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Hong
    • Hong Kong, Hong Hong, Hong Kong
      • Recruiting
      • Chinese University of Hong Kong
      • Principal Investigator: Vincent Mok, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AD subjects will be recruited from neurology cognitive disorder clinic of Prince of Wales Hospital. Age match normal control will be recruited from existing normal control studies.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal cognition; 75 subject without any of the following: subjective memory complaint and cognitive impairment base on cognitive assessments
Subjective Cognitive Disorder; 75 subjects without cognitive impairment based on cognitive cognitive assessments but with subject memory complaint
Mild Cognitive Impairment; 75 subjects with both subjective memory complaints and mild cognitive impairment base on cognitive assessments
Dementia; 75 subjects with both subjective memory complaints and moderate to severe cognitive impairment base on cognitive assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Amount of amyloid β with 11C-Pittsburgh compound B	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	Baseline
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
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
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
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Alzheimer Disease; Neurodegenerative Diseases
• Other Study ID Numbers: SEEDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No