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Prospective study of related factors and biomarkers in the predementia stage of Alzheimer's disease
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注册号:

Registration number:

ChiCTR2100052341 

最近更新日期:

Date of Last Refreshed on:

2021-12-23 

注册时间:

Date of Registration:

2021-10-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

阿尔茨海默病痴呆前阶段相关影响因素和生物标志物的前瞻性研究 

Public title:

Prospective study of related factors and biomarkers in the predementia stage of Alzheimer's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

阿尔茨海默病痴呆前阶段相关影响因素和生物标志物的前瞻性研究 

Scientific title:

Prospective study of related factors and biomarkers in the predementia stage 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:

谢兆宏 

研究负责人:

毕建忠 

Applicant:

Xie Zhaohong 

Study leader:

Bi Jianzhong 

申请注册联系人电话:

Applicant telephone:

+86 17660083369 

研究负责人电话:

Study leader's telephone:

+86 0531-85875005 

申请注册联系人传真 :

Applicant Fax:

88962544 

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:

xie_zhaohong@sdu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

bjz@sdu.edu.cn 

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:

山东省济南市北园大街247号 

研究负责人通讯地址:

山东省济南市北园大街247号 

Applicant address:

247 Beiyuan Street, Ji'nan, Shandong, China 

Study leader's address:

247 Beiyuan Street, Ji'nan, Shandong, 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:

山东大学第二医院 

Applicant's institution:

The Second Hospital of Shandong University 

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:

KYLL-2020(kJ)P-0142 

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:

山东大学第二医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the Second Hospital of Shandong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-01 

伦理委员会联系人:

王传新 

Contact Name of the ethic committee:

Wang Chuanxin 

伦理委员会联系地址:

山东省济南市北园大街247号 

Contact Address of the ethic committee:

247 Beiyuan Street, Jinan, Shandong, China 

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:

山东大学第二医院 

Primary sponsor:

The Second Hospital of Shandong University 

研究实施负责(组长)单位地址:

山东省济南市北园大街247号 

Primary sponsor's address:

247 Beiyuan Street, Jinan, Shandong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

ShanDong

City:

Jinan

单位(医院):

山东大学第二医院

具体地址:

山东省济南市北园大街247号

Institution
hospital:

The Second Hospital of Shandong University

Address:

247 Beiyuan Street, Jinan, Shandong, China

经费或物资来源:

山东大学临床研究重点项目 

Source(s) of funding:

Key clinical Research project of Shandong University 

研究疾病:

阿尔茨海默病 

Target disease:

Alzheimer's disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

开展队列研究探讨AD痴呆前阶段,包括主观认知减退(SCD)阶段和轻度认知功能障碍(MCI)阶段的相关影响因素,即危险因素和保护性因素;采用分子流行病学方法探索可用于AD痴呆前阶段,包括主观认知减退(SCD)阶段和轻度认知功能障碍(MCI)阶段诊断的相关生物标志物;基于AD痴呆前阶段包括SCD、MCI向AD痴呆阶段进展相关的影响因素和生物标志物,构建可用于进展预测的数学模型 

Objectives of Study:

Cohort studies were conducted to explore the risk factors and protective factors associated with the pre-stage of AD dementia, including subjective cognitive decline (SCD) and mild cognitive impairment (MCI).Molecular epidemiological approaches were used to explore biomarkers for the diagnosis of pre-dementia AD, including subjective cognitive decline (SCD) and mild cognitive impairment (MCI);Based on the influencing factors and biomarkers related to the progression from SCD and MCI to AD dementia stage, a mathematical model that can be used to predict progression was constructed 

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.SCD 纳入标准: ①与之前正常状态比,自我感觉持续的认知功能下降,且与急性事件无关。 ②经年龄、性别、受教育年限校正后,标准认知测试正常,有别于 MCI 和痴呆前驱期。①和②须同时具备。 2. MCI 纳入标准:符合 2011 年 NIA-AA 的 MCI 核心临床诊断标准: (1)符合 MCI 的临床表现: ①患者或知情者报告,或有经验的临床医师发现认知的损害; ②存在一个或多个认知功能域损害的客观证据(来自认知测验); ③复杂的工具性日常能力可以有轻微损害,但保持独立的日常生活能力; ④尚未达到痴呆的诊断。 (2)发病机制符合的 AD 病理生理过程: ①有纵向随访发现认知功能持续下降的证据; ②有与 AD 遗传因素相关的病 。 

Inclusion criteria

1. Inclusion criteria for SCD: (1) Self-perceived continuous decline in cognitive function, independent of acute events, compared with the previous normal state; (2) After adjusting for age, sex and years of education, the standard cognitive test was normal, which was different from MCI and predementias. (1) and (2) must be present together. 2. MCI inclusion criteria: in line with the 2011 NIA-AA core clinical diagnostic criteria for MCI: (1) Clinical manifestations consistent with MCI: 1) Cognitive impairment was reported by patients or informed persons, or found by experienced clinicians; 2) objective evidence of impairment of one or more cognitive domains (from cognitive tests); 3) complex instrumental daily abilities can be slightly impaired, but maintain independent daily living abilities; 4) The diagnosis of dementia has not been reached yet. (2) The pathophysiological process of AD consistent with the pathogenesis: 1) Evidence of continuous decline of cognitive function was found in longitudinal follow-up; 2) There are diseases related to AD genetic factors. 

排除标准:

1.年龄小于 60 岁; 2.各种原因导致的痴呆; 3.存在严重躯体疾病和/或重性精神疾病; 4.血管性、创伤性、医源性、精神疾病、内科疾病、感染、中毒、药物副作用或物质滥用、其他神经变性病等引起的认知功能减退; 5.视力和听力减退,不能完成该项研究。 

Exclusion criteria:

1. Less than 60 years old; 2. Dementia caused by various causes; 3. Severe physical illness and/or severe mental illness; 4. Cognitive decline caused by vascular, traumatic, iatrogenic, mental illness, medical disease, infection, poisoning, drug side effects or substance abuse, and other neurodegenerative diseases; 5. Impairment of vision and hearing and inability to complete the study. 

研究实施时间:

Study execute time:

From2020-07-01To 2023-06-30 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2023-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

20415

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

山东大学第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Hospital of Shandong University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

济南市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Jinan Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

威海 

Country:

China 

Province:

Shandong 

City:

Weihai 

单位(医院):

威海市立医院 

单位级别:

三甲医院 

Institution
hospital:

Weihai Municipal Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

招远 

Country:

China 

Province:

Shandong 

City:

Zhaoyuan 

单位(医院):

山东大学第二医院招远分院(山东玲珑英诚医院) 

单位级别:

三级医院 

Institution
hospital:

Zhaoyuan Branch of the Second Hospital of Shandong University (Shandong Linglong Yingcheng Hospital)  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

相对危险度

指标类型:

主要指标 

Outcome:

RR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

归因危险度

指标类型:

主要指标 

Outcome:

AR

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 (CSF)

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 60 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):

根据2010年全国第六次人口普查的数据,结合济南市、威海市、烟台市区和村镇的人口地域分布,以及年龄分布,本研究拟分别在济南市、威海市、烟台市随机各选取一个街道和一个乡镇,共包含约12万人,对其中60岁以上的人口,教育年限、婚姻、职业不限进行流行病学调查。

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

No

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

No

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):

不共享

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

Do not share

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:

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-10-24
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