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Effect of anti-aging tablets on improving cognitive function of Mild and moderate Alzheimer's disease

Registration number：

ITMCTR2100005443

Date of Last Refreshed on：

2021-12-24

Date of Registration：

2021-12-24

Registration Status：

Prospective registration

Public title：

Effect of anti-aging tablets on improving cognitive function of Mild and moderate Alzheimer's disease

English Acronym：

Scientific title：

Effect of anti-aging tablets on improving cognitive function of Mild and moderate Alzheimer's disease

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100054713 ; ChiMCTR2100005443

Applicant：

Guan jiangli

Study leader：

Zhang Xueping

Applicant telephone：

15880011053

Study leader's telephone：

13868081273

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1543174052@qq.com

Study leader's E-mail：

504499532@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

551 Xixi Road, Xihu District, Hangzhou City, Zhejiang Province

Study leader's address：

305 Tianmushan Road, Hangzhou City, Zhejiang Province, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Chia tai Whelk Bao pharmaceutical Co. LTD

Approved by ethic committee：

Approved No. of ethic committee：

（2021年）伦审第（050）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Review Committee of Hangzhou Seventh People's Hospital

Date of approved by ethic committee：

2021/7/27 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Hangzhou 7th People's Hospital / Mental Health Center affiliated to Zhejiang University School of Medicine

Primary sponsor's address：

305 Tianmushan Road, Hangzhou City, Zhejiang Province, China

Secondary sponsor：

Source(s) of funding：

Chia tai Whelk Bao pharmaceutical Co. LTD

Target disease：

Alzheimer's disease

Target disease code：

Study type：

Interventional study

Study design：

Randomly Sampling

Study phase：

Pilot clinical trial

Objectives of Study：

Based on TCM syndrome differentiation and classification, this study selected patients with mild and moderate AD in line with qi-Yin deficiency syndrome, combined with assessment scale, NUCLEAR magnetic resonance, cerebrospinal fluid biomarker detection or amyloid PET scan and intestinal microflora detection, and divided them into groups by random sampling. The clinical study was conducted for 6 months. To explore the effect of anti-aging tablets on improving cognitive function or delaying the disease of Alzheimer's disease, and to evaluate the safety of anti-aging tablets.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the probable diagnostic criteria of NINCDS-ADRDA for AD dementia, and the course of disease is ≥6 months. ② Simplified Mental State Assessment Scale (MMSE) (11≤MMSE score ≤26, 11≤MMSE score ≤24 for primary education); ③ Age ≥65 years old, ≤85 years old, male and female; ④ Have a primary school education or above and have the ability to complete the test required by the program. ⑤ Receive a comprehensive neuropsychological assessment; Hachinski ischemia scale ≤4 points; Hamilton Depression Scale (HAMD) ≤10; ⑥ Patients with deficiency of qi and Yin in TCM syndrome differentiation; There should be stable accompanying personnel, or at least 4 days a week, 2 hours a day contact with the accompanying personnel. The attendant should assist the patient throughout the trial;No obvious positive signs in neurological examination; ⑨ The patients and/or their family members sign the informed consent and agree to participate in all visits, examinations and treatment in accordance with the requirements of the study protocol.

Exclusion criteria：

① Exclude dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, lewy body dementia, etc.; Thyroid disease, parathyroid disease, alcoholism, drug intoxication, brain tumor, normal pressure hydrocephalus, etc. ② Pseudodementia caused by depression (HAMD≥17); ③ Routine laboratory studies, including vitamin B12 levels, folic acid levels and thyroid hormone levels; Quantitative HIV antibody and serological examination of syphilis were performed to exclude dementia patients caused by other factors. ④ patients with a history of mental illness (such as schizophrenia) or influence collaborators; ⑤ Exclude epilepsy, alcohol or psychotropic drug abuse history; ⑥ Acute stage of cardiovascular, lung, liver, kidney, hematopoietic system and other major body diseases; ⑦ There are contraindications to Mr Examination; ⑧ severe abnormalities of hearing and vision; ⑨ TCM syndrome differentiation: non-qi and Yin deficiency syndrome.

Study execute time：

From 2021-06-01

To      2023-05-31

Recruiting time：

From 2021-12-24

To      2022-12-31

Interventions：

15

Group：

Donepezil + anti-aging tablets (experimental group)

Sample size：

Intervention：

Donepezil + anti-aging tablets

Intervention code：

15

Group：

donepezil + anti-aging tablets Placebo group(control group)

Sample size：

Intervention：

donepezil + anti-aging tablets Placebo group

Intervention code：

Total sample size ： 30

Countries of recruitment
and research settings：

Country：

china

Province：

zhejiang

City：

hangzhou

Institution/hospital：

Hangzhou 7th People's Hospital

Level of the institution：

3 armour hospital

Outcomes：

Outcome：

community structure and composition of intestinal flora

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Head-MRI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Scale to assess

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

feces

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

65
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Use random sampling to group the mild and moderate AD patients with Qi and Yin Deficiency Syndrome, and use random number method to divide all research subjects into experimental group and control group. Odd numbers are included in the experimental group, and even numbers are included in the control gro

Blinding：

IPD sharing：

Yes

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

no

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

no

Data Managemen Committee：

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

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