复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的探索性临床研究

注册号:

Registration number:

ITMCTR2023000014

最近更新日期:

Date of Last Refreshed on:

2023-05-30

注册时间:

Date of Registration:

2023-05-30

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的探索性临床研究

Public title:

Exploratory clinical study of Compound Congrong Yizhi capsules in treating mild and moderate Alzheimer's disease

注册题目简写:

复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的临床研究

English Acronym:

Clinical study of Compound Congrong Yizhi capsules in treating mild and moderate Alzheimer's disease

研究课题的正式科学名称:

复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的探索性临床研究

Scientific title:

Exploratory clinical study of Compound Congrong Yizhi capsules in treating mild and moderate Alzheimer's disease

研究课题的正式科学名称简写:

复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的临床研究

Scientific title acronym:

Clinical study of Compound Congrong Yizhi capsules in treating mild and moderate 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:

卫东锋

研究负责人:

孙锦平

Applicant:

Wei Dongfeng

Study leader:

Jinping Sun

申请注册联系人电话:

Applicant telephone:

+86 18301311686

研究负责人电话:

Study leader's telephone:

+86 13705329393

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:

weidongfeng@aliyun.com

研究负责人电子邮件:

Study leader's E-mail:

lzq1771083@163.com

申请单位网址(自愿提供):

Study leader's 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:

北京市东城区东直门内南小街16号大白楼4楼

研究负责人通讯地址:

山东省青岛市市南区江苏路16号

Applicant address:

16 Nanxiao Street in Dongzhimen, Dongcheng District, Beijing

Study leader's address:

16 Jiangsu Road, Shinan District, Qingdao City, Shandong Province

申请注册联系人邮政编码:

Applicant postcode:

100700

研究负责人邮政编码:

Study leader's postcode:

100700

申请人所在单位:

中国中医科学院中医临床基础医学研究所

Applicant's institution:

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

QYFYEC2023-11

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

青岛大学附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the Affiliated Hospital of Qingdao University

伦理委员会批准日期:

Date of approved by ethic committee:

2023/2/1 0:00:00

伦理委员会联系人:

朱婕

Contact Name of the ethic committee:

Jie Zhu

伦理委员会联系地址:

青岛大学第一附属医院行政楼

Contact Address of the ethic committee:

Administration building of the First Affiliated hospital of Qingdao University

伦理委员会联系人电话:

Contact phone of the ethic committee:

0532-82911869

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:

青岛大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Qingdao University

研究实施负责(组长)单位地址:

山东省青岛市市南区江苏路16号

Primary sponsor's address:

16 Jiangsu Road, Shinan District, Qingdao City, Shandong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都医科大学宣武医院

具体地址:

北京市西城区长椿街45号宣武医院

Institution
hospital:

Xuan Wu Hospital, Capital Medical University

Address:

Xuanwu Hospital, 45 Changchun Street, Xicheng District, Beijing

国家:

中国

省(直辖市):

山东

市(区县):

青岛

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

青岛大学第一附属医院

具体地址:

山东省青岛市市南区江苏路16号

Institution
hospital:

The First Affiliated Hospital of Qingdao University

Address:

16 Jiangsu Road, Shinan District, Qingdao City, Shandong Province

经费或物资来源:

合作课题

Source(s) of funding:

Cooperation project

研究疾病:

阿尔茨海默

研究疾病代码:

Target disease:

Alzheimer’s disease

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

上市后药物

Post-marketing clinical trial

研究目的:

(1)评价复方苁蓉益智胶囊治疗轻中度阿尔茨海默病的疗效。 (2)评价复方苁蓉益智胶囊的药物安全性。

Objectives of Study:

(1) To evaluate the therapeutic effect of Compound Congrong Yizhi capsules on mild and moderate Alzheimer's disease. (2) To evaluate the drug safety of Compound Congrong Yizhi capsules.

药物成份或治疗方案详述:

药物组成:何首乌、荷叶、肉苁蓉、地龙、漏芦。 本试验采用中央随机、双盲、多中心的临床试验设计方法,评价复方苁蓉益智胶囊治疗阿尔茨海默病的有效性和安全性。本试验为上市后药物再评价研究。

Description for medicine or protocol of treatment in detail:

Drug composition: Reynoutria multiflora (Thunb.), Nelumbo nucifera Gaertn., Cistanche deserticola Ma, Pheretimaas pergillum(E Perrier), Echinops davuricus Fisch. ex Hornem. A central randomized, double-blind, multicenter clinical trial was designed to evaluate the efficacy and safety of compound Compound Congrong Yizhi capsules in the treatment of Alzheimer's disease. This study was a post-marketing drug reevaluation study.

纳入标准:

符合以下所有项目者方可纳入本次试验: (1)男性或女性,在签署ICF时年龄介于50-85岁之间。 (2)患者必须满足美国国家衰老研究所-阿尔茨海默病协会定义的很可能的AD标准; (3)在筛选访视时,简易精神状态量表得分为文盲组≤17分,小学组≤20分,初中组≤22分,高中组≤24分。 (4)在筛选时,患者的临床痴呆评定量表总评分≤2分,且记忆框评分必须≥0.5分,方能将患者诊断为轻中度AD。 (5)受试者应有稳定可靠的照料者,照料者将帮助受试者参与研究全过程。 (6)接受过至少5年教育,并具有参加所有检测所需的身体、认知、听力、言语、识字和语言能力。 (7)女性患者为绝经妇女(绝经≥24周)、或实施了外科绝育手术、或育龄女性同意在试验期间采取有效的避孕措施。育龄女性或者绝经时间短于24周的患者必须在筛选时做尿妊娠实验,结果须为阴性。 (8)在进行任何研究相关操作之前,必须获得经患者(或其法定代理人)和研究搭档签名和标明日期的知情同意书。

Inclusion criteria

Those who meet all the following items shall be included in this trial: (1)Male or female, aged between 50 and 85 years at the time of Informed Consent Form signing. (2)Patients must meet the probable Alzheimer's Disease criteria as defined by the National Institute on Aging-Alzheimer's Disease Association; (3)At the screening visit, the Simple Mental Status Scale scored 17 for the illiterate group, 20 for the primary school group, 22 for the middle school group and 24 for the high school group. (4)At screening, the total clinical dementia rating scale score is 2, and the memory frame score must be 0.5 to diagnose mild-to-moderate Alzheimer's Disease. (5)Subjects will have a stable and reliable caregiver who will assist the participant in the study. (6)With at least 5 years of education and the physical, cognitive, hearing, speech, literacy and language skills required to participate in all tests. (7)Female patients were menopausal women (24 weeks) or surgical sterilization, or women of childbearing age agreed to effective contraception during the trial. Women of childbearing age or patients with menopause time of less than 24 weeks must have urine pregnancy experiments at screening, and the results must be negative. (8)Informed consent forms, signed and dated by the patient (or her legal representative) and study partner, must be obtained prior to any study-related procedures.

排除标准:

(1)除AD之外,患者罹患累及中枢神经系统且可能影响认知或完成研究能力的重大和/或当前神经系统疾病,包括但不限于其他类型痴呆、重复性脑外伤、严重的脑感染、帕金森病、癫痫或脑血管疾病; (2)有不稳定或严重的心、肺、肝、肾、造血系统疾; (3)体内有植入金属材料、有幽闭恐惧症等磁共振检查禁忌症,因其他身心疾病导致无法完成神经心理测验及量表评定; (4)入组前三个月内参加过或正在参加其他药物试验者; (5)依从性差、严重疾病或生命垂危等不能完成疗程者; (6)近三个月内使用其他改善认知功能药物如ChEIs或其他精神类药物; (7)根据精神障碍诊断与统计手册 标准确定的12个月内不稳定或会干扰研究评估的精神疾病,包括精神分裂症或其他精神疾病、双相情感障碍、重度抑郁或谵妄; (8)存在对复方苁蓉益智胶囊和盐酸多奈哌齐片中任何成分过敏史。

Exclusion criteria:

(1)Patients with significant and/or current neurological disorders affecting cognition or study completion abilities, including but not limited to types of dementia other than Alzheimer's disease, repetitive brain trauma, severe brain infection, Parkinson's disease, epilepsy, or cerebrovascular diseases, are excluded from participation except for Alzheimer's disease. (2)Patients with unstable or severe cardiac, pulmonary, hepatic, renal, or hematopoietic system diseases are excluded. (3)Patients with contraindications for magnetic resonance imaging, such as implanted metallic materials or claustrophobia, and those who cannot complete neuropsychological tests and assessments due to other physical or mental illnesses are excluded. (4)Patients who have participated in or are currently participating in other drug trials within the three months prior to enrollment are excluded. (5)Patients with poor compliance, severe illness, or life-threatening conditions that prevent them from completing the treatment regimen are excluded. (6)Patients who have used other cognitive enhancer drugs such as Cholinesterase Inhibitors or other psychotropic medications in the past three months are excluded. (7)Patients with unstable psychiatric disorders or those diagnosed with psychiatric illnesses within the last 12 months as per the Diagnostic and Statistical Manual of Mental Disorders criteria, including schizophrenia or other psychiatric disorders, bipolar disorder, severe depression, or delirium, which may interfere with the study assessments, are excluded. (8)Patients with a history of allergies to any component of Compound Cognition Capsules or Donepezil Hydrochloride Tablets are excluded.

研究实施时间:

Study execute time:

From 2023-02-01

To      2026-02-28

征募观察对象时间:

Recruiting time:

From 2023-06-01

To      2024-06-01

干预措施:

Interventions:

组别:

复方苁蓉益智胶囊组

样本量:

30

Group:

Compound Congrong Yizhi capsules Group

Sample size:

干预措施:

复方苁蓉益智胶囊,0.3g/粒,4粒/次,一日3次

干预措施代码:

Intervention:

Compound Congrong Yizhi capsules. 0.3g/ capsule, 4 capsules/time, 3 times a day

Intervention code:

组别:

盐酸多奈哌齐片组

样本量:

30

Group:

Donepezil hydrochloride tablets group

Sample size:

干预措施:

盐酸多奈哌齐片,5mg/次,一日1次

干预措施代码:

Intervention:

Donepezil Hydrochloride Tablets, 5mg/ time, once a day

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东省

市(区县):

青岛市

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

青岛大学附属医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Qingdao University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都医科大学宣武医院

单位级别:

三级甲等

Institution/hospital:

Xuan Wu Hospital, Capital Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

影像学检查

指标类型:

次要指标

Outcome:

Imageological examination

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

核磁共振

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

MRI

指标中文名:

老年脑健康中医证候量表

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine syndrome scale of senile brain health

Type:

Secondary indicator

测量时间点:

基线,12周和24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 12 and 24 weeks

Measure method:

Scale measurement

指标中文名:

听觉词语记忆测验

指标类型:

次要指标

Outcome:

Auditory Verbal Learning Test

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

阿尔茨海默病评估量表

指标类型:

主要指标

Outcome:

Alzheimer’s disease assessment scale

Type:

Primary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

血浆生物标记物指标

指标类型:

次要指标

Outcome:

Plasma biomarker indicators

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

血浆检测

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Plasma assay

指标中文名:

Rey-Osterrich 复杂图形回忆

指标类型:

次要指标

Outcome:

Rey-Osterrieth complex figure

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

简明精神状态检查量表

指标类型:

次要指标

Outcome:

Mini-Mental State Examination

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

连线测验

指标类型:

次要指标

Outcome:

Trail making test

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

所有回忆评分的总和

指标类型:

次要指标

Outcome:

Auditory Verbal Learning Test-Tatal

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

临床痴呆量表

指标类型:

次要指标

Outcome:

Clinical Dementia Rating

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

临床医生面试和照料者补充的总体印象变化量表

指标类型:

次要指标

Outcome:

Clinicians’ Interview-Based Impression Changescale

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

指标中文名:

日常生活能力

指标类型:

次要指标

Outcome:

Activities of daily living

Type:

Secondary indicator

测量时间点:

基线,24周

测量方法:

量表测评

Measure time point of outcome:

Base line, after 24 weeks

Measure method:

Scale measurement

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

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

结束

Completed

年龄范围:

最小 50
Min age years
最大 85
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究计划用SAS 9.4(或以上版本)统计软件产生随机编码,采用中央随机化的方法,将受试者按1:1的比例随机分配到试验组或对照组。本研究考虑到药物外观及给药剂量的差异,未采用盲法。

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

In this study, SAS 9.4 (or above) statistical software was used to generate random coding, and subjects were randomly assigned to the experimental or control groups in a 1:1 ratio by central randomization. The blind method was not used in this study considering the differences in drug appearance and dosage.

盲法:

Blinding:

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):

研究结束后通过论文形式共享原始数据

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

Share raw data in paper form after research

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:

为确保数据的准确性,由两个数据管理员独立进行双份录入并校对,数据录入过程中任何数据修改系统均有记录。完成录入后进行数据质量稽查,随机抽取若干病例报告表,与数据库核对一致性,以确保数据库中的数据与原始CRF表中的结果一致。对病例报告表中存在的疑问,数据管理员将产生疑问解答表,并通过临床监查员向研究者发出询问,研究者应尽快解答并返回,数据管理员根据研究者的回答进行数据修改、确认与录入,必要时可以再次发出疑问解答表。对病例报告表中存在的疑问,依据数据核查计划,通过系统程序核查与人工核查产生并向研究者发出疑问解答表,并通过临床监查员向研究者者发出询问。研究者对疑问表中的问题进行书面解答并签名后,数据录入员根据答疑内容修改数据库。必要时可再次发出疑问。

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

To ensure the accuracy of the data, two data managers independently entered and proofread the data in duplicate, and any data modification system was recorded during the data entry process. After completion of the entry, a data quality audit was conducted, and a number of case report forms were randomly selected to check consistency with the database to ensure that the data in the database were consistent with the results in the original Case report form. If there are any questions in the case report form, the data manager will generate a question answer form and send it to the researcher through the clinical monitor. The researcher should answer and return it as soon as possible. The data manager will modify, confirm and enter the data according to the answers of the researcher, and can send question answer form again when necessary. According to the data verification plan, a question answer form was generated and sent to the investigators through systematic procedure verification and manual verification, and questions were sent to the investigators through clinical monitors. After the researcher provided written answers and signed the questions in the query form, the data entry clerk modified the database according to the answers. Questions can be asked again if necessary.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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