Identificazione dei biomarcatori nella malattia di 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Pualine Kwan
- Numero di telefono: +852 26352160
- Email: paulinekwan@cuhk.edu.hk
Backup dei contatti dello studio
- Nome: Elyia Han
- Numero di telefono: +852 2697 5027
- Email: elyiahan@cuhk.edu.hk
Luoghi di studio
-
-
Hong Hong
-
Hong Kong, Hong Hong, Hong Kong
- Reclutamento
- Chinese University of Hong Kong
-
Investigatore principale:
- Vincent Mok, MD
-
Contatto:
- Elyia Han, Bachelor
- Numero di telefono: +852 26975027
- Email: elyiahan@cuhk.edu.hk
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The score change in Hong Kong List Learn Test (HKLLT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SEEDS
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .