Neuro-Degenerative DiseaseSEEDSNCT05655650
Identifying Biomarkers in Alzheimer's Disease
An observational study of Neuro-Degenerative Disease and Alzheimer Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease, Alzheimer Disease
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Clinical diagnosis of non-AD dementia
- contraindication for MRI or PET
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong, Hong Hong
Elyia Han, Bachelor, +852 26975027, elyiahan@cuhk.edu.hk
Vincent Mok, MD
About this study
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.
Read the 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.
- Conditions
- Neuro-Degenerative Disease, Alzheimer Disease
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6th year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Sep 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Mok, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655650
- Sponsor's protocol ID
- SEEDS
- Acronym
- SEEDS
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05655650
- Acronym / sponsor ID
- SEEDS / SEEDS
- Conditions
- Neuro-Degenerative Disease, Alzheimer Disease
- Keywords
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Clinical diagnosis of non-AD dementia
- contraindication for MRI or PET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Degenerative Disease and Alzheimer Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pualine Kwan (+852 26352160, paulinekwan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.