ChiCTR2000036842 版本V1.5 版本创建时间2020/09/20 04:22:41 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2000036842 

最近更新日期：

Date of Last Refreshed on：

2020-09-20 04:21:54 

注册时间：

Date of Registration：

2020-08-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

ATN系统临床前期AD神经影像队列的建设

Public title：

Construction of pre-clinical AD neuroimaging cohort of ATN system

注册题目简写：

English Acronym：

研究课题的正式科学名称：

ATN系统临床前期AD神经影像队列的建设

Scientific title：

Construction of pre-clinical AD neuroimaging cohort of ATN system

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：

李骏鹏 

研究负责人：

管一晖 

Applicant：

Junpeng Li 

Study leader：

Yihui Guan 

申请注册联系人电话：

Applicant telephone：

+86 18051063617

研究负责人电话：

Study leader's telephone：

+86 13764308300

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：

lijunpeng08@126.com

研究负责人电子邮件：

Study leader's E-mail：

guanyihui@hotmail.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：

上海市徐汇区吴中东路518号

研究负责人通讯地址：

上海市徐汇区吴中东路518号

Applicant address：

518 Wuzhong Road East, Xuhui District, Shanghai, China

Study leader's address：

518 Wuzhong Road East, Xuhui 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：

复旦大学附属华山医院

Applicant's institution：

Huashan Hospital Affiliated to Fudan University

研究负责人所在单位：

复旦大学附属华山医院

Affiliation of the Leader：

Huashan Hospital Affiliated to Fudan University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

（2020）临审第（942）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：

复旦大学附属华山医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Huashan Hospital Affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2020-08-21 00:00:00

伦理委员会联系人：

冯晓源，伍蓉

Contact Name of the ethic committee：

Xiaoyuan Feng, Rong Wu

伦理委员会联系地址：

上海市乌鲁木齐中路12号

Contact Address of the ethic committee：

12 Urumqi middle Road, Jing'an 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：

复旦大学附属华山医院PET中心

Primary sponsor：

PET Center, Huashan Hospital Affiliated to Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区吴中东路518号

Primary sponsor's address：

518 Wuzhong Road East, Xuhui 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)：

复旦大学附属华山医院

具体地址：

上海市乌鲁木齐中路12号

Institution
hospital：

Huashan Hospital Affiliated to Fudan University

Address：

12 Urumqi Middle Road, Jing'an District

经费或物资来源：

专项资金

Source(s) of funding：

specific fund

Target disease：

Alzheimer's Disease

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：

0

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 

研究目的：

1.建立包含A/T/N体系标志物的中国人AD神经影像数据库，探究不同生物标志物在AD进展过程中的变化和作用机理，为AD的早期诊断及防治提供精准化方案； 2.建立基于中国人的Aβ、tau及FDG脑PET分布谱图，并建立其显像方法和分析方法，将其应用于AD的早期诊断和鉴别诊断中，以及治疗管理方案的制定中； 3.探究临床前期AD中，脑内tau的改变情况与Aβ和FDG的关系，确认tau在早期AD中的作用及其AD进展过程中的变化过程和作用。 4. 建立早期AD诊断的预测模型，利用生物标志物及临床资料，影像资料，基因等数据，建立完善预测模型，预测发病风险，尽早进行干预。  

Objectives of Study：

1. Establish a Chinese AD neuroimaging database containing A/T/N system markers, explore the changes and mechanism of action of different biomarkers in the progression of AD, and provide precise solutions for the early diagnosis and prevention of AD; 2. Establish a Chinese-based Aβ, tau and FDG brain PET distribution spectrum, and establish its imaging and analysis methods, and apply them to the early diagnosis and differential diagnosis of AD, as well as the formulation of treatment management plans; 3. Explore the relationship between the changes of tau in the brain and Aβ and FDG in the preclinical stage of AD, confirm the role of tau in early AD and its change process and role in the progression of AD. 4. Establish a prediction model for early AD diagnosis, use biomarkers, clinical data, imaging data, genetic data and other data to establish a perfect prediction model, predict the risk of disease, and intervene as soon as possible.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 非疾病对照者：
a.年龄在45~90岁之间；性别不限。
b.经研究者通过认知测试认定认知功能正常。CDR评分为0分。
c.经研究者确认无神经系统疾病、重大慢性疾病、恶性肿瘤或急性传染病等。
d.无AD家族史，无与认知障碍、运动障碍有关的神经系统性疾病家族史。
e.在进行任何评估之前，理解并签署书面知情同意书。
f.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究阶段采取隔绝避孕措施。
g.男性受试者须在本研究阶段采取隔绝避孕措施。男性受试者本研究期间不得捐献精子。
h.愿意并且有能力配合本研究的所有项目。
2. AD患者：
a.年龄在45~90岁之间；性别不限。
b.患者符合AD诊断标准 （NIA-AA 2011)。
c.CDR评分≥0.5分。
d.MMSE评分≤28分。
e.脑MRI支持AD诊断，并且无其他神经系统疾病证据。
f.用于改善AD临床症状的药物须以稳定剂量维持30天以上才可进行开始本研究。
g.须由受试者或其法定监护人、照看者书面签署的知情同意书。
h.如有必要，受试者可由护理人员能够伴随受试者。
i.在进行任何评估之前，受试者或其法定代理人理解并签署书面知情同意书。
j.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究阶段采取隔绝避孕措施。
k.男性受试者须在本研究阶段采取隔绝避孕措施。男性受试者本研究期间不得捐献精子。
l.愿意并且有能力配合本研究的所有项目。

Inclusion criteria

1. Non-disease controls:
(1) Between 45 and 90 years old; gender is not limited;
(2) The cognitive function is determined to be normal by the researcher through cognitive tests. The CDR score is 0 points;
(3) Confirmed by the researcher that there is no neurological disease, major chronic disease, malignant tumor or acute infectious disease, etc.;
(4) No family history of AD, no family history of neurological diseases related to cognitive impairment and movement disorder;
(5) Understand and sign a written informed consent before any assessment;
(6) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must take isolated contraception during this research phase Measures.
(7) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study;
(8) Willing and able to cooperate with all projects of this research.
2. AD patients:
(1) Between 45 and 90 years old; gender is not limited.
(2) The patient meets the AD diagnostic criteria (NIA-AA 2011);
(3) CDR score >=0.5 points;
(4) MMSE score <=28 points;
(5) Brain MRI supports the diagnosis of AD, and there is no evidence of other neurological diseases;
(6) The drugs used to improve the clinical symptoms of AD must be maintained at a stable dose for more than 30 days before starting this study;
(7) A written informed consent form signed by the subject or his legal guardian or caregiver;
(8) If necessary, the subject can be accompanied by a nursing staff;
(9) Before any assessment, the subject or his legal representative understands and signs a written informed consent;
(10) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must take isolated contraception during this research phase Measures.
(11) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study;
(12) Willing and able to cooperate with all projects of this research.

排除标准：

1. 所有受试者：
a.患有严重的其他神经系统疾病，或胃肠道、心血管、肝脏、肾脏、血液系统、肿瘤、内分泌、呼吸系统、免疫缺陷及其他严重疾病。
b.曾植入无法兼容MRI检查的金属装置，可包括心脏起搏器、血管内金属装置、胰岛素泵、人工耳蜗、神经刺激器、脑动脉瘤夹片等。
c.无法耐受MRI噪音或者患有密闭恐惧症。
d.在过去一年内，因其他临床医疗或科学研究需要，接受过本实验范畴以外的电离辐射，从而使年辐射暴露剂量超过50 mSv。
e.药物滥用或酗酒史。
f.妊娠期或哺乳期妇女。
g.静脉条件差，无法耐受重复静脉穿刺。
h.1个月内接受过（效果或安全性不明确的）试验性药物或器械治疗。
i.静脉条件差，无法耐受重复静脉穿刺。
h.可能对[18F]PM-PBB3注射液组分过敏。
j.具有任何本研究主持者认为本试验相关任何环节可能造成危害或有潜在危害性的状况。
2. AD患者
a.3个月内接受过针对Aβ的药物治疗。
b.3个月内接受过针对tau的药物治疗。

Exclusion criteria：

1. All subjects:
(1) Suffer from serious other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other serious diseases;
(2) Metal devices that are not compatible with MRI have been implanted, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, cerebral aneurysm clips, etc.;
(3) Cannot tolerate MRI noise or suffer from occlusion phobia;
(4) In the past year, due to other clinical medical or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50 mSv;
(5) History of drug abuse or alcohol abuse;
(6) Women during pregnancy or lactation;
(7) Poor venous conditions, unable to tolerate repeated venipuncture;
(8) Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month;
(9) Poor venous conditions, unable to tolerate repeated venipuncture;
(10) May be allergic to the components of [18F]PM-PBB3 injection;
(11) There is any situation that the research leader believes that any link related to this experiment may cause harm or have potential harm;
2. AD patients
(1) Received drug treatment for Aβ within 3 months;
(2) Received medication for tau within 3 months.

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 2021-01-01 00:00:00 至 To 2022-01-01 00:00:00  

诊断试验：

Diagnostic Tests：

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）：

2011年美国国立老化研究所与阿尔茨海默病协会（National Institute on Aging -Alzheimer’s Association, NIA-AA）

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):

2011 diagnostic criteria of the National Institute on Aging-Alzheimer’s Association (NIA-AA).

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）：

18F-FDG、18F-AV45、118F-MK6240的PET/MR显像

Index test:

PET/MR imaging of 18F-FDG, 18F-AV45, 118F-MK6240

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）

AD、轻度认知受损（Mild cognitive impairment, MCI）、主观认知障碍（SCD）

例数:

Sample size:

0

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):

AD, Mild cognitive impairment (MCI), Subjective Cognitive Decline (SCD)

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）：

主观轻微认知症状,客观轻微认知症状

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:

Subjective Slight Cognitive Syndrome，Sub-SCS. Objective Slight Cognitive Syndrome，Obj-SCS

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)：

复旦大学附属华山医院伽马分院 

单位级别：

三甲医院 

Institution
hospital：

Gamma Branch of Huashan Hospital, Fudan University

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

PET/MR显像

指标类型：

主要指标

Outcome：

PET/MR imaging

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：

无

组织：

Sample Name：

None

Tissue：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing

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）：

2023年3月31日与华山医院PET中心官网公开：https://www.huashan.org.cn/pet/

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

Public on the official website of Huashan Hospital PET Center on March 31, 2023 : https://www.huashan.org.cn/pet/

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：

患者心理测验量表由上海市第六人民医院老年医学科郭起浩教授团队采集和管理，PET/MR成像数据管理于华山医院PET中心Sygo.via影像工作站

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

The patient psychological test scale was collected and managed by the team of Professor Guo Qihao, Department of Geriatrics, Shanghai Sixth People's Hospital, and the PET/MR imaging data was managed at the Sygo.via imaging workstation of the PET Center of Huashan Hospital

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：

  2020-08-25 10:55:50