SEEDS: Identifying Biomarkers in Alzheimer's Disease

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05655650

Collaborator

(none)

300

Enrollment

Location

148

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuro-Degenerative Disease Alzheimer 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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Identifying Biomarkers in Alzheimer's Disease

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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
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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese University of Hong Kong	Hong Kong	Hong Hong	Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vincent Mok, Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05655650

Other Study ID Numbers:

SEEDS

First Posted:

Dec 19, 2022

Last Update Posted:

Dec 19, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vincent Mok, Professor, Chinese University of Hong Kong

Alzheimer Disease

Additional relevant MeSH terms:

Alzheimer Disease

Neurodegenerative Diseases

Study Results

No Results Posted as of Dec 19, 2022