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SCD空间导航神经环路的轻微损害特征预测AD转化的机制
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注册号:

Registration number:

ChiCTR1900022526 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

SCD空间导航神经环路的轻微损害特征预测AD转化的机制 

Public title:

The role of characteristics of mild spatial navigation impairment in people with subjective cognitive decline in predicting Alzheimer's disease progression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

SCD空间导航神经环路的轻微损害特征预测AD转化的机制 

Scientific title:

The role of characteristics of mild spatial navigation impairment in people with subjective cognitive decline in predicting Alzheimer's disease progression 

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:

青钊 

研究负责人:

张冰 

Applicant:

Zhao Qing 

Study leader:

Bing Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13701451581 

研究负责人电话:

Study leader's telephone:

+86 15851803070 

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:

qz2004012239@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangbing_nanjing@nju.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:

江苏省南京市鼓楼区中山路321号南京鼓楼医院 

研究负责人通讯地址:

江苏省南京市鼓楼区中山路321号南京鼓楼医院 

Applicant address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

南京鼓楼医院 

Applicant's institution:

Affiliated Drum Tower Hospital of Nanjing University Medical School 

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:

2017-105-01 

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:

南京大学医学院附属鼓楼医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Affiliated Drum Tower Hospital of Nanjing University Medical School 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-08-08 

伦理委员会联系人:

沙莉莉 

Contact Name of the ethic committee:

Lili Sha 

伦理委员会联系地址:

江苏省南京市鼓楼区中山路321号南京鼓楼医院 

Contact Address of the ethic committee:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

南京鼓楼医院 

Primary sponsor:

Affiliated Drum Tower Hospital of Nanjing University Medical School 

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区中山路321号 

Primary sponsor's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京大学医学院附属鼓楼医院影像科

具体地址:

江苏省南京市鼓楼区中山路321号

Institution
hospital:

Department of Radiology, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China

Address:

321 Zhongshan Road, Nanjing, Jiangsu, China

经费或物资来源:

中国国家自然科学基金 

Source(s) of funding:

Chinese National Natural Science Foundation 

研究疾病:

轻度认知障碍/主观认知下降 

Target disease:

mild cognitive impariment/subjective cognitive decline 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

以空间导航障碍为切入点,研发人脑空间导航-影像检测系统,探索SCD在AD疾病谱中转化的神经机制和客观生物学标志物,有望成为解决痴呆患者迷路和走失等常见临床问题的突破点。 

Objectives of Study:

It is expected to be a breakthrough point to solve the common clinical problems of dementia patients, such as getting lost and getting lost, by developing the human brain's spatial navigation and image detection system and exploring the neural mechanism and objective biological markers of SCD transformation in AD spectrum. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

入选标准 a)根据如下诊断标准确定入组,每组至少 30例。按性别、年龄、受教育程度对各组进行匹配。 b)按照研究目的招募被试,经下述认知评分确定认知水平。 c)按性别、年龄、受教育程度对各组进行匹配。 d)总体认知分级量表评估在磁共振检查当天或一周内完成。 e)本项目在成熟的诊断技术下进行,本项目由医院伦理委员会讨论通过,对主诉认知异常或自愿参加本研究的老年人告知本研究的方法及安全事项,取得 知情同意,请受试者签署知情同意书。(见附件)。 f)行为学测试在当天完成,神经心理学评分在三天内完成 , 由鼓楼医院神经内科医师和老年神经科医师、神经病学研究生完成,并会诊签署疾病诊断意见。 SCD 诊断标准。参照2014 年Frank Jessen 提出的标准: ① 年龄大于等于60 岁。 ② 患者自述较过去正常状态相比,有记忆下降。 ③ 用于评估MCI 或者AD 早期的标准化认知测试结果正常。 ④ 第二点和第三点必须同时满足。 ⑤ 排除:MCI、AD 前驱期或痴呆;可由精神或神经疾病(AD 除外)、 内科疾病、药物等解释的疾病。 MCI 诊断标准。参照2001 年美国神经学会质量标准分会推荐的 Petersen 等1999 年提出的标准: ① 主诉记忆障碍,而且有知情者证实;有记忆损害的客观证据。 ② 总体认知分级量表轻度异常(教育年龄8 年以上):MMSE 25~26 分; MoCA 19~25 分;CDR 0.5 分;Hachinski 缺血指数表(Rosen 法)得 分小于等于4 分,以除外血管性痴呆及混合性痴呆。日常生活能力 正常或轻微受损(20 项ADL 量表,正常值20 分)。 ③ MRI 入组标准:除脑萎缩和深部白质少量脱髓鞘病变(Fazekas scale I级及以下)外,无其它异常改变。 进展型MCI 诊断标准。根据Petersen, R.C. (J Intern Med, 2004) 及Whitwell JL (Brain, 2007) 文献提示,aMCI 每年约12~15%进展为AD,随访6 年后有80%转化为AD。 ① 随访 6 年后确诊为AD 或其他类型痴呆者,在其转化为痴呆前的状 态可以确诊为进展型MCI。 ② 每年随访 MCI 患者,其MMSE 分数持续下降,下降2 分以上。 可能AD(probable AD)诊断标准:参照《精神疾病诊断及统计手册第四版修订版(DSM-IV)》和美国国立神经研究院沟通障碍、中风-Alzheimer 病及相关障碍协会(NINCDS-ADRDA) 标准。 ① 客观证据表明确有短期或长期记忆损害。 ② 有以下8 个认知区域的一种或一种以上认知功能障碍:记忆、语言、 注意、执行能力、定向力、抽象思维与判断力损害、其它皮质功能 的障碍、人格改变。 上述两类认知功能损害明显干扰社交、职业活动或人际关系。 ④ 总体认知分级量表异常(教育年龄8 年以上):MMSE ≤24 分, 20~24 分(轻度),16~19 分(中度), 15 分以下(重度);MoCA<19 分; CDR 1 分(轻度), 2 分(中度), 3 分(重度);ADL>20 分,Hachinski 缺血指数表≤4 分。 ⑤ MRI 入组标准同前。 认知正常老年人对照组(NC)。 参照2008 年美国国家卫生部(U.S. National institutes of health, NIH)认知功能障碍研究项目提出的对照组标准。 ① 无主诉记忆障碍。 ② 总体认知分级量表正常: MMSE 27~30 分; MoCA 26~30 分; CDR 0 分; ADL 正常20 分。 Hachinski 缺血指数表≤4 分。 ③ MRI 入组标准同前 

Inclusion criteria

1. diagnostic criteria determine into the group, at least 30 cases in each group. The groups were matched according to gender, age and education level; 2. subjects were recruited for the purpose of the study, and their cognitive level was determined by the following cognitive scores; 3. match each group according to gender, age and education level; 4. the assessment of the general cognitive rating scale was completed on the day of the MRI examination or within one week; 5. the project is carried out under mature diagnostic technology. The project is discussed and approved by the ethics committee of the hospital. Elderly patients who complain of cognitive abnormalities or voluntarily participate in the study are informed of the methods and safety issues of the study, and informed consent is obtained. (see attachment). 6. behavioral test should be completed on the same day, neuropsychological score should be completed within three days, and it should be completed by neurologists, geriatric neurologists and neurology graduate students in gulou hospital, and the disease diagnosis opinions should be signed for consultation. SCD diagnostic criteria: Meet Frank Jessen 2014 standard: (1) aged more than equal to 60 years old; (2) compared with the normal state in the past, the patient reported a decline in memory; (3) The standardized cognitive test results used to evaluate early MCI or AD were normal; (4) The second point and the third point must be satisfied at the same time; (5) exclusion: MCI, AD prodrome or dementia; Except by mental or neurological disease (AD), medical disease, drugs such as interpretation of disease. MCI diagnostic criteria: With reference to the 2001 quality standards subcommittee recommended by American society for neural Petersen standard proposed by 1999: (1) complained of a memory disorders, and insider confirmed; Objective evidence of memory impairment; (2) mild abnormalities in the overall cognitive rating scale (education age over 8 years) : MMSE 25 ~ 26 points; MoCA 19 ~ 25 points; CDR 0.5 points; Fares Hachinski ischemia (Rosen method) was less than or equal to 4 points, except for vascular dementia and mixed dementia. Daily life ability of normal or slightly damaged (20 ADL scale, normal 20 points); (3) MRI inclusion criteria: except for brain atrophy and a small amount of demyelinating lesions in deep white matter (Fazekas scale I and below), there were no other abnormal changes. Diagnostic criteria for progressive MCI: According to the literature of Petersen, R.C. (J Intern Med, 2004) and Whitwell JL (Brain, 2007), about 12 ~ 15% of aMCI progress to AD every year, and 80% of them are converted to AD after 6 years of follow-up. (1) been followed up for 6 years later diagnosed with AD or other types of dementia, the state before it into dementia can progress in diagnosis of MCI; (2) patients with MCI were followed up every year, and their MMSE scores continued to decline, down by more than 2 points. Probable AD: it is probable that the diagnostic and statistical manual of mental disorders, dsm-iv, and the nincds-adrda criteria will be considered. Objective evidence shows that there is short-term or long-term memory damage; (3) has the following eight cognitive areas of one or more cognitive dysfunction: memory, language, attention, executive ability, abstract thinking and judgment, directional force damage, other cortical function disorders, personality changes. These two types of cognitive impairment significantly interfere with social, professional activities or interpersonal relationships; (4) abnormalities in the overall cognitive rating scale (education age of more than 8 years): MMSE 24, 20 ~ 24 (mild), 16 ~ 19 (moderate), 15 or less (severe); MoCA < 19 points; CDR score: 1 (mild), 2 (moderate), 3 (severe); ADL > 20 points, Hachinski ischemia experienced four points or less; (5) MRI inclusion criteria were the same as before. Cognitively normal elderly control group (NC): With reference to the National ministry of health in 2008 (the U.S. National institutes of health, NIH) research project put forward the control standard cognitive dysfunction. (1) no chief complaint memory disorder; (2) the overall cognitive rating scale was normal: MMSE 27 ~ 30; MoCA score: 26 ~ 30 points; CDR 0; ADL 20 normal. Hachinski ischemia index table 4 scores. The MRI enrollment criteria were the same as before 

排除标准:

排除标准参照美国NIH(National Institute of Health)及Petersen等 提出的标准 ① 其他痴呆相关的神经系统疾病或既往2年内患抑郁症(HAMD评分 ≥17) ② 既往5年内其他任何显著的系统性疾病 ③ 短暂性脑缺血发作蛛网膜下腔出血、缺/出血性梗死、脑肿瘤病史 等。 ④ 嗜酒史及药物滥用史。 

Exclusion criteria:

Refer to National institutes of Health and Petersen et al.: (1) other dementia-related neurological diseases or previous depression within 2 years (HAMD score or higher; (2) any other significant systemic disease within the previous 5 years; (3) transient ischemic attack, subarachnoid hemorrhage, ischemic/hemorrhagic infarction, history of brain tumor And so on; (4) history of alcohol and drug abuse. 

研究实施时间:

Study execute time:

From2018-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

AD/MCI/pMCI/SCD/NC

样本量:

600

Group:

AD/MCI/pMCI/SCD/NC

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京市 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院影像科 

单位级别:

三甲 

Institution
hospital:

Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

MRI影像学指标

指标类型:

主要指标 

Outcome:

MRI features

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空间导航行为学

指标类型:

主要指标 

Outcome:

spatial navigation performance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知量表评分

指标类型:

主要指标 

Outcome:

Cognitions Scales

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:

静脉采血

Sample Name:

blood

Tissue:

venous blood sampling

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction 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 80 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):

实验设计未包含随机

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

ResMan

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

ResMan

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:

本地硬盘

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

local hard disk

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-15
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