An Exploratory Randomized Controlled Trial of Acupuncture Combined with Cognitive Training for Mild to Moderate Alzheimer's Disease Patients

注册号:

Registration number:

ITMCTR2025000200

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

针刺联合认知训练治疗轻中度阿尔茨海默病患者的探索性随机对照试验

Public title:

An Exploratory Randomized Controlled Trial of Acupuncture Combined with Cognitive Training for Mild to Moderate Alzheimer's Disease Patients

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺联合认知训练治疗轻中度阿尔茨海默病患者的探索性随机对照试验

Scientific title:

An Exploratory Randomized Controlled Trial of Acupuncture Combined with Cognitive Training for Mild to Moderate Alzheimer's Disease Patients

研究课题的正式科学名称简写:

Scientific title acronym:

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:

鄢锦荣

研究负责人:

贾宝辉

Applicant:

Yanjinrong

Study leader:

JiaBaohui

申请注册联系人电话:

Applicant telephone:

17745122857

研究负责人电话:

Study leader's telephone:

13520090050

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:

3093971445@qq.com

研究负责人电子邮件:

Study leader's E-mail:

myrroossee@aliyun.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:

北京市朝阳区北三环东路11号

研究负责人通讯地址:

北京市西城区北线阁5号

Applicant address:

11 Beisanhuan East Road Chaoyang District Beijing

Study leader's address:

No.5 North Line Pavilion Xicheng District Beijing

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:

北京中医药大学

Applicant's institution:

Beijing University of Chinese Medicine

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:

2023-253-KY-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

中国中医科学院广安门医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee Guang 'anmen Hospital China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/3 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Qiaojie

伦理委员会联系地址:

北京市西城区北线阁5号

Contact Address of the ethic committee:

No.5 North Line Pavilion Xicheng District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-8800-1552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市西城区北线阁5号

Primary sponsor's address:

No.5 North Line Pavilion Xicheng District Beijing

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

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Address:

No.5 North Line Pavilion Xicheng District Beijing

经费或物资来源:

北京市中医药科技发展资金项目

Source(s) of funding:

Beijing Traditional Chinese Medicine Science and Technology Development Fund Project

研究疾病:

阿尔茨海默病

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

评价开展针刺联合认知训练治疗轻中度AD患者研究方案的可行性; 探讨针刺联合认知训练对轻中度AD患者的整体认知功能、日常生活能力的影响。

Objectives of Study:

To evaluate the feasibility of Acupuncture Combined with Cognitive Training for the treatment of mild to moderate AD patients. To explore the effects of Acupuncture Combined with Cognitive Training on the overall cognitive function and daily living ability of mild to moderate AD patients.

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. 符合 NIA-AA 标准中很可能 AD 标准; 2. 50 岁≤年龄≤85 岁; 3. 0.5 分≤临床痴呆评定评分≤2 分; 4. Hachinski 缺血量表评分≤4 分; 5. 签署知情同意书,自愿参加本试验; 6. 若受试者本人有能力做决定, 则由本人签署知情同意书; 若受试者有能 力做决定,但由于文化水平低无法签署知情同意时,在获取本人同意后, 须有见证人见证知情同意的过程,并作为见证人签署知情同意;若受试者本人没有能力做出知情同意的决定,应获得其法定代理人的知情同意; 7. 能够听从指示,没有任何听觉或视觉障碍。

Inclusion criteria

1. In line with the NIA-AA standard is likely to be AD standard; 2. 50 years ≤ age ≤85 years; 3. 0.5 score ≤ clinical dementia rating score ≤2 score; 4. Hachinski Ischemia Scale score ≤4 points; 5.Sign informed consent and participate in the experiment voluntarily; 6. If the subject is capable of making a decision he/she will sign the informed consent; If the subject has the ability to make decisions but cannot sign informed consent due to low educational level after obtaining the consent of the subject a witness must witness the process of informed consent and sign the informed consent as a witness; If the subject does not have the ability to make informed consent he/she should obtain informed consent from his/her legal representative. 7. Able to follow instructions without any hearing or visual impairment.

排除标准:

1.伴有严重脑血管疾病; 2.伴有其他能够引起认知功能障碍或进行性记忆损害的疾病; 3.药物引起的认知功能障碍或进行性记忆损害; 4.患有严重心血管疾病、恶性肿瘤、重度肝肾功能不全的患者; 5.严重畏针、晕针,皮肤严重感染的患者; 6.高度依赖护理设施的患者; 7.最近 2 周内接受过针灸治疗、认知训练的患者; 8.入组时正在参与其他临床试验。

Exclusion criteria:

1.Accompanied by severe cerebrovascular disease; 2.With other diseases that can cause cognitive dysfunction or progressive memory impairment; 3.Drug-induced cognitive dysfunction or progressive memory impairment; 4.Patients with severe cardiovascular diseases malignant tumors and severe hepatic and renal insufficiency; 5.Patients with severe fear of needles faintness and severe skin infection; 6.Patients who are highly dependent on care facilities; 7.Patients who received acupuncture treatment and cognitive training in the last 2 weeks; 8.Participants who simultaneously participating in other clinical trials upon the enrollment.

研究实施时间:

Study execute time:

From 2023-09-01

To      2025-08-31

征募观察对象时间:

Recruiting time:

From 2024-06-03

To      2025-05-31

干预措施:

Interventions:

组别:

单纯针刺组

样本量:

13

Group:

Simple acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

针刺联合认知训练组

样本量:

13

Group:

acupuncture combined with cognitive training group

Sample size:

干预措施:

针刺联合认知训练

干预措施代码:

Intervention:

acupuncture combined with cognitive training

Intervention code:

组别:

认知训练组

样本量:

13

Group:

cognitive training group

Sample size:

干预措施:

认知训练

干预措施代码:

Intervention:

cognitive training

Intervention code:

组别:

假针刺组

样本量:

13

Group:

fake acupuncture group

Sample size:

干预措施:

假针刺

干预措施代码:

Intervention:

fake acupuncture

Intervention code:

样本总量 Total sample size : 52

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

北京大学人民医院

单位级别:

三级甲等医院

Institution/hospital:

Peking University People's Hospital

Level of the institution:

Grade 3A hospital

国家:

中国

省(直辖市):

北京市

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

中国中医科学院广安门医院

单位级别:

三级甲等中医院

Institution/hospital:

Guang 'anmen Hospital China Academy of Chinese Medical Sciences

Level of the institution:

Third class A traditional Chinese medicine hospital

国家:

中国

省(直辖市):

北京市

市(区县):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

首都医科大学宣武医院

单位级别:

三级甲等医院

Institution/hospital:

Xuanwu Hospital of Capital Medical University

Level of the institution:

Class III Grade A hospital

测量指标:

Outcomes:

指标中文名:

临床医师会晤总体印象变化基线量表

指标类型:

次要指标

Outcome:

Clinician Interview–Based Impression of Change scale CIBIC

Type:

Secondary indicator

测量时间点:

基线,第24周;治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

At baseline week 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

治疗满意度调查

指标类型:

次要指标

Outcome:

Treatment Satisfaction Survey

Type:

Secondary indicator

测量时间点:

治疗结束后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

After treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

阿尔茨海默病评价量表-认知分量表

指标类型:

主要指标

Outcome:

Alzheimers disease assessment scale cognition ADAS-Cog

Type:

Primary indicator

测量时间点:

基线期,第8周,第16周,第24周,治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

At baseline week 8 16 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

Zarit照顾负担量表

指标类型:

次要指标

Outcome:

Zarit Caregiving Burden Scale ZBI

Type:

Secondary indicator

测量时间点:

基线,第24周;治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

At baseline week 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

神经精神问卷患者评分

指标类型:

次要指标

Outcome:

Neuropsychiatric Questionnaire Patient Score

Type:

Secondary indicator

测量时间点:

基线,第8周,第16周,第24周;治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

At baseline week 8 16 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

神经精神问卷护理者苦恼评分

指标类型:

次要指标

Outcome:

Neuropsychiatric Questionnaire Nursing Distress Score

Type:

Secondary indicator

测量时间点:

基线,第8周,第16周,第24周;治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估。

Measure time point of outcome:

At baseline week 8 16 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

指标中文名:

日常生活能力量表

指标类型:

次要指标

Outcome:

Activities of Daily Living ADL

Type:

Secondary indicator

测量时间点:

基线,第8周,第16周,第24周;治疗结束4周后

测量方法:

由不参与治疗和评价的专人负责量表评估

Measure time point of outcome:

At baseline week 8 16 24 and 4 weeks after the end of treatment

Measure method:

The person who is not involved in the treatment and evaluation is responsible for the scale evaluation.

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

正在进行

Recruiting

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):

由不参与治疗和评价的专人负责随机信封和分配。将样本量52及组数4输入SPSS26.0统计软件中,随后产生随机数字及分组数,制作随机数字卡,装入不透光、密封的信封中,随机抽取信封取卡,严格按照卡片序号分组,分为①单纯针刺组;②认知训练组;③针刺+认知训练组;④假针刺组。将随机数字和组别密封于不透光的信封内进行随机分配隐藏。

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

A person not involved in the treatment and evaluation is responsible for the random envelope and distribution. The sample size 52 and group number 4 were input into SPSS26.0 statistical software then random numbers and group numbers were generated and random number cards were prepared and put into opaque and sealed envelopes. Envelopes were randomly selected to take cards and the cards were divided into ①simple acupuncture group strictly according to the card serial number; ② Cognitive Training group; ③ Acupuncture combined with Cognitive Training group; ④ False acupuncture group. Random numbers and groups are sealed in light-tight envelopes for random assignment hiding.

盲法:

Blinding:

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):

不适用

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

Not Applicable

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

No

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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