Identifying Biomarkers in Alzheimer's Disease

NCT05655650 | Recruiting DMC

• 1 other identifier: SEEDS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuro-Degenerative Disease; Alzheimer Disease

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Clinical diagnosis of non-AD dementia
• contraindication for MRI or PET

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Hong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, blood cells

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Pualine Kwan

CONTACT

+852 26352160; paulinekwan@cuhk.edu.hk

Elyia Han

CONTACT

+852 2697 5027; elyiahan@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: September 1, 2018
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

HK (1)