中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2000036718
最近更新日期： Date of Last Refreshed on：	2020-09-20 10:26:31
注册时间： Date of Registration：	2020-08-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	利用人工智能构建人机对话版认知筛查成套量表的研究
Public title：	Research on developing a set of human-computer interactive electronic neuropsychological assessment toolkit assisted by artificial intelligence
注册题目简写：
English Acronym：
研究课题的正式科学名称：	利用人工智能构建人机对话版认知筛查成套量表的研究
Scientific title：	Research on developing a set of human-computer interactive electronic neuropsychological assessment toolkit assisted by artificial intelligence
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：	王刚	研究负责人：	王刚
Applicant：	Gang Wang	Study leader：	Gang Wang
申请注册联系人电话： Applicant telephone：	+86 15900616110	研究负责人电话： Study leader's telephone：	+86 15900616110
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：	wg11424@rjh.com.cn	研究负责人电子邮件： Study leader's E-mail：	wg11424@rjh.com.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：	上海市黄浦区瑞金二路197号	研究负责人通讯地址：	上海市黄浦区瑞金二路197号
Applicant address：	197 Second Ruijin Road, Huangpu District, Shanghai, China	Study leader's address：	197 Second Ruijin Road, Huangpu District, Shanghai, 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：	上海交通大学医学院附属瑞金医院
Applicant's institution：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
研究负责人所在单位：	上海交通大学医学院附属瑞金医院
Affiliation of the Leader：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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：	2020-261	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：	瑞金医院伦理委员会
Name of the ethic committee：	Ethics Committee of Ruijin Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2020-08-20 00:00:00
伦理委员会联系人：	王译峰
Contact Name of the ethic committee：	Yifeng Wang
伦理委员会联系地址：	上海市黄浦区瑞金二路197号
Contact Address of the ethic committee：	197 Second Ruijin Road, Huangpu District, Shanghai, 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：

上海交通大学医学院附属瑞金医院

Primary sponsor：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市黄浦区瑞金二路197号

Primary sponsor's address：

197 Second Ruijin Road, Huangpu District, Shanghai, 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	具体地址：	黄浦区瑞金二路197号
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Address：	197 Second Ruijin Road, Huangpu District

经费或物资来源：

申康重大临床研究项目

Source(s) of funding：

Shenkang

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：

0

研究设计：

连续入组

Study design：

Sequential

研究目的：

阿尔茨海默病（Alzheimer’s Disease, AD）,也就是通常所说的老年痴呆，是痴呆最常见的类型。轻度认知功能障碍（Mild Cognitive Impairment，MCI）是介于正常衰老和老年痴呆之间的一种临床前阶段，MCI患者是罹患老年痴呆的高危人群。为提高MCI和轻度AD的筛查效率，降低大范围社区筛查成本，达到“三早”的二级预防目标，本研究拟探索开发一套人机对话版电子化神经心理学评估工具包，更全面地评估受试者的认知状态；从而构建适用于人群筛查、精确诊断的人工智能辅助系统，在分级诊疗体系中实现规模化示范应用。

Objectives of Study：

Alzheimers Disease (AD), also known as aging dementia, is the most common type of dementia. Mild Cognitive Impairment (MCI) is a preclinical stage between normal aging and Alzheimers disease. MCI patients are at high risk of Alzheimers disease. In order to improve the efficiency of early screening for MCI and mild AD, reduce the cost of large-scale community screening, and achieve the "three early" secondary prevention goals, this study intends to explore the development of a set of human-computer interactive electronic neuropsychological assessment toolkit. This will contribute to assessing the cognitive status of subjects more comprehensively; thereby constructing an artificial intelligence assisted system applicable for population screening and accurate diagnosis. Last but not least, this will realize large-scale demonstration applications in the hierarchical diagnosis and treatment system.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age ranges from 55 to 80; males and females;
2. Medication: Not taking anti-dementia and cognitive improvement drugs systematically;
3. Clinical Dementia Rating (CDR)scale =0.5; Diagnostic criteria for MCI:
(1) cognitive impairment reported by patients or insiders, or discovered by experienced clinicians; 
(2) There is objective evidence of impairment in one or more cognitive function domains (from cognitive tests);
(3) Complicated instrumental daily ability can be slightly impaired, but independent daily ability maintained;
(4) The diagnosis of dementia has not yet been reached;
Mild AD meets NIA-AA diagnostic criteria (CDR=1):
(1) impaired work or daily activities; (2) Life function and executive ability decline than previous levels; (3) Cannot be explained by delirium or other serious psychiatric disorders; (4) Cognitive disorders are discovered and diagnosed based on medical history collection and objective cognitive evaluation; (5) Cognitive or behavioral impairment includes at least two aspects: learning and remembering new information; reasoning and processing complex tasks and judgment; visual space ability; language function (speaking, reading, writing); personality or behavior changes. And has the following characteristics:
(1) insidious onset;
(2) a clear history of cognitive deterioration is reported or observed;
(3) The initial and major cognitive impairment found in medical history inquiry and physical examination belongs to the following categories: amnestic manifestations; non-amnestic manifestations (language disorder, visual space disorder or executive dysfunction).
4. The subject should have a stable and reliable caregiver who can accompany the subject when necessary for examination or treatment.

排除标准：

1. 具有癫痫或抽搐发作病史;
2. 装有植入性设备（如心脏起博器、医学泵或人工耳蜗等）；颅内（非口腔内）存在任何金属制品（如弹片、外科夹或支架（钛材料除外）等）；埋植神经刺激器（DBS或皮下迷走神经刺激器等）;
3. 其他原因引起的认知功能减退：脑血管病、中枢神经系统感染、克-雅病、亨廷顿舞蹈症和帕金森病、路易体痴呆、脑外伤性痴呆、其他理化因素（药物、酒精、CO等）、重要躯体疾病（肝性脑病、肺性脑病等）、颅内占位性病变（硬膜下血肿、脑肿瘤）、内分泌系统病变（甲状腺疾病、甲状旁腺疾病）以及维生素或其他任何原因引起的痴呆；
4. 精神病患者，符合DSM-IV标准的精神分裂症或其他精神疾病，双向情感障碍，重性抑郁或谵妄；
5. 存在不可纠正的视觉、听觉障碍无法完成量表等相关检测；
6. 研究人员认为该受试者不可能完成本研究。

Exclusion criteria：

1. Have a history of seizures or convulsions;
2. Equipped with implantable devices (such as cardiac pacemakers, medical pumps or cochlear implants, etc.); any metal products (such as shrapnel, surgical clips or stents (except titanium), etc.) exist in the skull (not in the oral cavity); implanted Nerve stimulator (DBS or subcutaneous vagus nerve stimulator, etc.);
3. Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntingtons disease and Parkinsons disease, Lewy body dementia, traumatic brain dementia, other physical and chemical factors (drugs, alcohol, CO, etc.) ), important physical diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying disease (subdural hematoma, brain tumor), endocrine system disease (thyroid disease, parathyroid disease), vitamins or dementia caused by any other reasons;
4. Schizophrenia, bipolar disorder, major depression, delirium or other psychiatric disorders that meet the DSM-IV criteria;
5. Patients with uncorrectable visual and hearing impairments that cannot complete the scales and other related tests;
6. The researcher believes that the subject is unlikely to complete the study.

研究实施时间：

Study execute time：

从 From 2020-10-01 00:00:00至 To 2022-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-10-01 00:00:00 至 To 2022-09-01 00:00:00

干预措施：

Interventions：

组别：	case series	样本量：	2000
Group：	case series	Sample size：	2000
干预措施：	无	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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	单位级别：	三级甲等
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	认知评估测试得分	指标类型：	主要指标
Outcome：	scores of cognitive assessment battery	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：	无	组织：
Sample Name：	N/A	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	55	岁 years
最大 Max age	80	岁 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）：

无

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

Not use

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	Not stated
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not stated
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；电子采集及云端存储
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF；Electronic collection and cloud storage
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2020-08-24 22:59:29