Clinical trial NCT05655650: Identifying Biomarkers in Alzheimer's Disease
Official title: Identifying Biomarkers in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuro-Degenerative Disease
Alzheimer Disease
Keywords: Alzheimer Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: The score change in Hong Kong List Learn Test (HKLLT)
timeFrame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
measure: The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA)
timeFrame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
measure: The score change Clinical Dementia Rating (CDR)
timeFrame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
measure: Amount of amyloid β with 11C-Pittsburgh compound B
timeFrame: Baseline
measure: Amount of amyloid tau with T807 tracer
timeFrame: Baseline
measure: Amount of glucose hypometabolism
timeFrame: Baseline
measure: arterial spin labeling magnetic resonance perfusion (ASL-MRP)
timeFrame: Baseline
measure: Change of Automatic Retinal Imaging
timeFrame: Baseline, 6th year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
state: Hong Hong
Study officials:
References: