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NCT Number: NCT05655650

Identifying Biomarkers in Alzheimer's Disease

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.

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Key information

Conditions

Neuro-Degenerative Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong Kong

Hong Kong, Hong Hong

Location status: Recruiting

Location contact

Elyia Han, Bachelor

CONTACT

[email protected]

+852 26975027

Vincent Mok, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elyia Han

CONTACT

[email protected]

+852 2697 5027

Pualine Kwan

CONTACT

[email protected]

+852 26352160

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: SEEDS

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Dec 19, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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