- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05655650
알츠하이머병의 바이오마커 식별 (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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Pualine Kwan
- 전화번호: +852 26352160
- 이메일: paulinekwan@cuhk.edu.hk
연구 연락처 백업
- 이름: Elyia Han
- 전화번호: +852 2697 5027
- 이메일: elyiahan@cuhk.edu.hk
연구 장소
-
-
Hong Hong
-
Hong Kong, Hong Hong, 홍콩
- 모병
- Chinese University of Hong Kong
-
수석 연구원:
- Vincent Mok, MD
-
연락하다:
- Elyia Han, Bachelor
- 전화번호: +852 26975027
- 이메일: elyiahan@cuhk.edu.hk
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The score change in Hong Kong List Learn Test (HKLLT)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .