- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05655650
Identifier des biomarqueurs dans la maladie d'Alzheimer (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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pualine Kwan
- Numéro de téléphone: +852 26352160
- E-mail: paulinekwan@cuhk.edu.hk
Sauvegarde des contacts de l'étude
- Nom: Elyia Han
- Numéro de téléphone: +852 2697 5027
- E-mail: elyiahan@cuhk.edu.hk
Lieux d'étude
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Hong Hong
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Hong Kong, Hong Hong, Hong Kong
- Recrutement
- Chinese University of Hong Kong
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Chercheur principal:
- Vincent Mok, MD
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Contact:
- Elyia Han, Bachelor
- Numéro de téléphone: +852 26975027
- E-mail: elyiahan@cuhk.edu.hk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
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Normal cognition
75 subject without any of the following: subjective memory complaint and cognitive impairment base on cognitive assessments |
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Subjective Cognitive Disorder
75 subjects without cognitive impairment based on cognitive cognitive assessments but with subject memory complaint |
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Mild Cognitive Impairment
75 subjects with both subjective memory complaints and mild cognitive impairment base on cognitive assessments |
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Dementia
75 subjects with both subjective memory complaints and moderate to severe cognitive impairment base on cognitive assessments |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The score change in Hong Kong List Learn Test (HKLLT)
Délai: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit
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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)
Délai: 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)
Délai: 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
Délai: 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
|
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Amount of amyloid tau with T807 tracer
Délai: 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
|
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Amount of glucose hypometabolism
Délai: 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
|
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arterial spin labeling magnetic resonance perfusion (ASL-MRP)
Délai: Baseline
|
Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects |
Baseline
|
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Change of Automatic Retinal Imaging
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SEEDS
Informations sur les médicaments et les dispositifs, documents d'étude
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