Today is 2019-12-14

Study for blood biomarkers of Alzheimer's disease
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注册号:

Registration number:

ChiCTR1900027622 

最近更新日期:

Date of Last Refreshed on:

2019-11-21 

注册时间:

Date of Registration:

2019-11-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阿尔茨海默病血液生物标志物的研究 

Public title:

Study for blood biomarkers of Alzheimer's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

阿尔茨海默病血液生物标志物的研究 

Scientific title:

Study for blood biomarkers of Alzheimer's disease 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

范冬雨 

研究负责人:

王延江 

Applicant:

Fan Dongyu 

Study leader:

Wang Yanjiang 

申请注册联系人电话:

Applicant telephone:

+86 18691571136 

研究负责人电话:

Study leader's telephone:

+86 15023653506 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

fffandongyu@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wayaja@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

重庆市渝中区长江支路10号 

研究负责人通讯地址:

重庆市渝中区长江支路10号 

Applicant address:

10 Changjiang Branch Road, Yuzhong District, Chongqing, China 

Study leader's address:

10 Changjiang Branch Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

陆军军医大学大坪医院 

Applicant's institution:

Army Medical University Daping Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

医研伦审(2019)第14号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国人民解放军陆军特色医学中心伦理委员会 

Name of the ethic committee:

Ethics Committee of the Chinese People's Liberation Army Army Specialized Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-11 

伦理委员会联系人:

段宏彦 

Contact Name of the ethic committee:

Duan Hongyan 

伦理委员会联系地址:

重庆市渝中区长江支路10号大坪医院 

Contact Address of the ethic committee:

10 Changjiang Branch Road, Yuzhong District, Chongqing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

陆军军医大学大坪医院 

Primary sponsor:

Army Medical University Daping Hospital 

研究实施负责(组长)单位地址:

重庆市渝中区长江支路10号 

Primary sponsor's address:

10 Changjiang Branch Road, Yuzhong District, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学大坪医院

具体地址:

渝中区长江支路10号

Institution
hospital:

Army Medical University Daping Hospital

Address:

10 Changjiang Branch Road, Yuzhong District

经费或物资来源:

大坪医院科研项目 

Source(s) of funding:

scientific grant of dating hospital 

研究疾病:

阿尔茨海默症 

Target disease:

Alzheimer's disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

探究血液中Aβ、Tau、NFL等生物标志物与脑脊液生物标志物的相关性及其对阿尔茨海默症的诊断和早期诊断价值。 

Objectives of Study:

To explore the correlation of biomarkers such as Aβ, Tau, NFL between blood and cerebrospinal fluid and its diagnostic and early diagnostic value for Alzheimer's disease. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1)年龄55岁以上(含55岁); 2)愿意行静脉采血和腰椎穿刺; 3)认知未受损者(对照组) 符合2011年NIA-AA颁布的AD诊断标准(AD组); 4)愿意参加本研究并签署知情同意书。 

Inclusion criteria

1) Age 55 or older (including 55 years old); 2) Willing to take venous blood collection and lumbar puncture; 3) Cognitive unimpaired (control group) Meets the diagnostic criteria for AD issued by the 2011 NIA-AA (AD group); 4) Willing to participate in the study and sign the informed consent form. 

排除标准:

1)颅内感染或全身感染; 2)严重冠心病、心功能不全、房颤等心脏疾病; 3)严重肝、肾功能不全; 4)严重血液系统疾病; 5)急性卒中、颅内肿瘤、多发性硬化等中枢神经系统疾病; 6)晚期全身恶性肿瘤。 

Exclusion criteria:

1) Intracranial infection or systemic infection; 2) Cardiac diseases such as severe coronary heart disease, cardiac insufficiency, and atrial fibrillation; 3) Severe liver and kidney dysfunction; 4) Severe blood system diseases; 5) Central nervous system diseases such as acute stroke, intracranial tumor, and multiple sclerosis; 6) Advanced systemic malignant tumors. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-06-30 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

NIA-AA 阿尔茨海默症诊断标准(2011)

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

NIA-AA Alzheimer's Criteria(2011)

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

A beta 40, A beta 42, T-Tau, p-Tau, NFL, NSE, CHI3L1, H-FABP, TREM2, VILIP, alpha-synuclein

Index test:

A beta 40, A beta 42, T-Tau, p-Tau, NFL, NSE, CHI3L1, H-FABP, TREM2, VILIP, alpha-synuclein

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

1.阿尔茨海默症患者 诊断标准:⑴+⑵至⑸中至少一项 ⑴早期、显著的情景记忆障碍。 ⑵存在内颞叶萎缩:MRI定性或定量测量发现海马结构、内嗅皮层、杏仁核体积缩小(参考同年龄人群的常模)。 ⑶脑脊液生物标记物异常:Aβ1-42降低、总tau(t-tau)或磷酸化tau(p-tau)增高,或三者同时存在。 ⑷PET的特殊表现:双侧颞叶糖代谢减低,其他有效的配体如FDDNP预见AD病理的改变。 ⑸直系亲属中有已证实的常染色体显性遗传突变导致的AD。 2.正常认知未受损人群人群

例数:

Sample size:

150

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

1. Alzheimer's disease patients Diagnostic criteria: at least one of (1) + (2) to (5) (1) Early, significant episodic memory impairment. (2) The presence of internal temporal lobe atrophy: MRI qualitative or quantitative measurement found that hippocampal formation, entorhinal cortex, amygdala volume shrink

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学大坪医院 

单位级别:

三级甲等医院 

Institution
hospital:

Army Medical University Daping Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

Aβ40

指标类型:

主要指标 

Outcome:

Aβ40

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T-Tau

指标类型:

主要指标 

Outcome:

Tau

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Aβ42

指标类型:

主要指标 

Outcome:

Aβ42

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

p-Tau

指标类型:

主要指标 

Outcome:

p-Tau

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NFL

指标类型:

主要指标 

Outcome:

NFL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

脑脊液

组织:

Sample Name:

Cerebrospinal fluid

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

陆军军医大学大坪医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Army Medical University Daping Hospital

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-21
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