- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05655650
Identifiera biomarkörer vid Alzheimers sjukdom (SEEDS)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Pualine Kwan
- Telefonnummer: +852 26352160
- E-post: paulinekwan@cuhk.edu.hk
Studera Kontakt Backup
- Namn: Elyia Han
- Telefonnummer: +852 2697 5027
- E-post: elyiahan@cuhk.edu.hk
Studieorter
-
-
Hong Hong
-
Hong Kong, Hong Hong, Hong Kong
- Rekrytering
- Chinese University of Hong Kong
-
Huvudutredare:
- Vincent Mok, MD
-
Kontakt:
- Elyia Han, Bachelor
- Telefonnummer: +852 26975027
- E-post: elyiahan@cuhk.edu.hk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The score change in Hong Kong List Learn Test (HKLLT)
Tidsram: 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 |
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)
Tidsram: 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 |
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)
Tidsram: 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 |
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
Tidsram: 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 |
Baseline
|
|
Amount of amyloid tau with T807 tracer
Tidsram: 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 |
Baseline
|
|
Amount of glucose hypometabolism
Tidsram: 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 |
Baseline
|
|
arterial spin labeling magnetic resonance perfusion (ASL-MRP)
Tidsram: Baseline
|
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
Tidsram: 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 |
Baseline, 6th year follow up
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SEEDS
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