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Recruiting NCT05655650

Identifying Biomarkers in Alzheimer's Disease

Observational Neuro-Degenerative Disease Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neuro-Degenerative Disease, Alzheimer Disease. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • 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 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 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]
  • Amount of amyloid β with 11C-Pittsburgh compound B [Time frame: Baseline]
  • Amount of amyloid tau with T807 tracer [Time frame: Baseline]
  • Amount of glucose hypometabolism [Time frame: Baseline]
  • arterial spin labeling magnetic resonance perfusion (ASL-MRP) [Time frame: Baseline]
  • Change of Automatic Retinal Imaging [Time frame: Baseline, 6th year follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT05655650 · SEEDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗