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Identifikation af biomarkører i Alzheimers sygdom (SEEDS)

16. september 2026 opdateret af: Vincent Mok, Chinese University of Hong Kong

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Pualine Kwan
Telefonnummer: +852 26352160
E-mail: paulinekwan@cuhk.edu.hk

Undersøgelse Kontakt Backup

Navn: Elyia Han
Telefonnummer: +852 2697 5027
E-mail: elyiahan@cuhk.edu.hk

Studiesteder

Hong Kong
- Hong Hong
  - Hong Kong, Hong Hong, Hong Kong
    - Rekruttering
    - Chinese University of Hong Kong
    - Ledende efterforsker:
      
      Vincent Mok, MD
    - Kontakt:
      
      Elyia Han, Bachelor
      
      Telefonnummer: +852 26975027
      
      E-mail: elyiahan@cuhk.edu.hk

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: PROSPECTIVE

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The score change in Hong Kong List Learn Test (HKLLT) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2018

Primær færdiggørelse (Anslået)

31. december 2030

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

9. december 2022

Først indsendt, der opfyldte QC-kriterier

9. december 2022

Først opslået (Faktiske)

19. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Alzheimers sygdom

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

SEEDS

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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