Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management

NCT ID: NCT05641480

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-03
• Study Completion Date: 2025-12-09

Brief Summary

This is a study on patient registry, and the sample size of this clinicaltrial is designed in group sequential design. According to the diagnostic criteria, the subjects are divided into SCD group, MCI group and mild dementia group. At the early stage of treatment, the investigators give participants transcutaneous electrical acupoint stimulation and music therapy according to the guidance of TCM syndrome differentiation. Participants can treat themselves at home after the investigators give them intelligent device and music，and according to the TCM syndrome score, neuropsychological scale, curative effect evaluation of daily life ability scale, determining the optimal comprehensive treatment plan,and phase in the treatment of participants with food, clothing, shelter, line, and life aspects of health education and guidance, a total of 24 weeks of treatment.

Detailed Description

As China progresses toward an aging society, the prevalence of geriatric diseases increases with it, especially in the case of Alzheimer's Disease (AD), the main clinical features of which are memory loss, cognitive dysfunction and behavioral impairment. At present, the disease is the fourth cause of death in the world after heart disease, tumor and stroke, which seriously causes heavy economic and social burden. Because the etiology of AD is not clear and the pathogenesis is complex, there is still a lack of effective treatment to curb its progress.

This project focuses on alzheimer's disease, according to the law of development for a disease to occur, combined with traditional Chinese medicine theory, the investigators according to the guidance of syndrome differentiation for participants with percutaneous acupoint stimulation and music therapy intervention plan.Mild dementia participants increase donepezil hydrochloride tablets or carbalatine bitartrate tablets. The therapeutic effect is evaluated once at 4 weeks and 8 weeks during the treatment period, and once at 12 weeks and 24 weeks during the follow-up period, a total of 4 times. After the treatment, the number of cases with stable condition, the number of cases with normal condition and the number of cases with disease transformation are calculated according to the diagnostic criteria. The efficacy and caregiver burden are evaluated according to dementia syndrome scale and neuropsychological scale.

In recent years, traditional Chinese medicine (TCM) has been expanding in the field of AD research. The individualized treatment methods of syndrome differentiation and treatment, as well as the multi-target and multi-means intervention techniques have obvious curative effects on improving cognitive status and delaying the progression of the disease, without obvious side effects and adverse reactions.Acupoint stimulation methods, such as acupuncture, warm moxibustion, acupoint application, electrical stimulation are all used to dredge human meridians to adjust the spirit, strengthen the brain and improve cognitive function. Therefore, the above comprehensive TCM intervention program may be the key link in the early prevention and treatment of AD.

This is a study on patient registry, and the sample size of this clinicaltrial is designed in group sequential design. According to the diagnostic criteria, the subjects are divided into SCD group, MCI group and mild dementia group. At the early stage of treatment, the the investigators give participants transcutaneous electrical acupoint stimulation and music therapy according to the guidance of TCM syndrome differentiation. Participants can treat themselves at home after the investigators give them intelligent device and music，and according to the TCM syndrome score, neuropsychological scale, curative effect evaluation of daily life ability scale, determining the optimal comprehensive treatment plan,and phase in the treatment of participants with food, clothing, shelter, line, and life aspects of health education and guidance, a total of 24 weeks of treatment.

Conditions

Alzheimer Disease; Subjective Cognitive Decline; Mild Cognitive Impairment; Mild Dementia

Keywords

Alzheimer's Disease; Subjective Cognitive Decline; Mild Cognitive Impairment; Mild Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subjective cognitive decline group

Studies suggest that acupuncture point Shenting can reduce the levels of serum inflammatory factors IL-6 and TNF-α, and the activity of cholinesterase of these two inflammatory factors is increased, and the activity of cholinacetylase is inhibited, which leads to brain tissue damage, nerve damage and cognitive dysfunction. Shenting（DU24）, Benshen（BG13） and Tou Wei（ST8） are the acupoints on the forehead, which have the effect of awakening the brain. Moreover, after acupuncture, nerve and periosteum effects can be caused, so as to improve cognitive function.

Music therapy is a convenient and efficient method, and as a non-drug intervention, activate the memory to help people with Alzheimer's disease, trigger positive emotions, improve the symptoms of behavior, the moment of life in participants with Alzheimer's disease has great significance, is a good way to help participants with slow disease progression and improve the quality of life, increase happiness of life.

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulation&Music therapy

Intervention Type: DEVICE

Procedure: electro-acupuncture;Points: Shenting（DU24）, Benshen（BG13）, Tou Wei （ST8）.The specially-made pad is stick on pierced acupoints, until local sour and heavy feeling coming. The electric stimulator is applied to bilateral BG13 and ST8, with dilatational wave,10/50 Hz and electric current 1-5mA(milliampere).Every session lasts for 30 min per day. The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each participants in all.

Selecting the participants' music of memory and music of favourite(Music is purchased and downloaded from music stores), forming a personalized music playlist, and the decibel level is suitable for participants.

The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

Other Names:

• JS-502-A Intelligent and portable electroacupuncture
• apparatus(Han's low frequency neuromodulator, made in China)

Mild cognitive impairment group

Studies suggest that acupuncture point Shenting can reduce the levels of serum inflammatory factors IL-6 and TNF-α, and the activity of cholinesterase of these two inflammatory factors is increased, and the activity of cholinacetylase is inhibited, which leads to brain tissue damage, nerve damage and cognitive dysfunction. Shenting（DU24）, Benshen（BG13） and Tou Wei（ST8） are the acupoints on the forehead, which have the effect of awakening the brain. Moreover, after acupuncture, nerve and periosteum effects can be caused, so as to improve cognitive function.

Music therapy is a convenient and efficient method, and as a non-drug intervention, activate the memory to help people with Alzheimer's disease, trigger positive emotions, improve the symptoms of behavior, the moment of life in participants with Alzheimer's disease has great significance, is a good way to help participants with slow disease progression and improve the quality of life, increase happiness of life.

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulation&Music therapy

Intervention Type: DEVICE

Procedure: electro-acupuncture;Points: Shenting（DU24）, Benshen（BG13）, Tou Wei （ST8）.The specially-made pad is stick on pierced acupoints, until local sour and heavy feeling coming. The electric stimulator is applied to bilateral BG13 and ST8, with dilatational wave,10/50 Hz and electric current 1-5mA(milliampere).Every session lasts for 30 min per day. The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each participants in all.

Selecting the participants' music of memory and music of favourite(Music is purchased and downloaded from music stores), forming a personalized music playlist, and the decibel level is suitable for participants.

The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

Other Names:

• JS-502-A Intelligent and portable electroacupuncture
• apparatus(Han's low frequency neuromodulator, made in China)

Mild dementia group

On the basis of the above two treatment options, oral donepezil hydrochloride tablets or carpalatine heavy tartrate tablets should be added.

Group Type: EXPERIMENTAL

Donepezil hydrochloride tablets or carpalatine bitartrate tablets

Intervention Type: DRUG

① Donepezil hydrochloride tablets 5 mg, once a day, one tablet each time, before going to bed. The treatment period is 6 months.

② Carpalatine heavy tartrate tablets 1.5mg, 1 tablet/time 2 weeks before treatment, twice a day, breakfast and dinner with food, swallow. If there is no obvious adverse reaction after 2 weeks, the dosage can be increased to 2 tablets/time, twice a day. The treatment period is 6 months.

Interventions

Transcutaneous electrical acupoint stimulation&Music therapy

Procedure: electro-acupuncture;Points: Shenting（DU24）, Benshen（BG13）, Tou Wei （ST8）.The specially-made pad is stick on pierced acupoints, until local sour and heavy feeling coming. The electric stimulator is applied to bilateral BG13 and ST8, with dilatational wave,10/50 Hz and electric current 1-5mA(milliampere).Every session lasts for 30 min per day. The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each participants in all.

Selecting the participants' music of memory and music of favourite(Music is purchased and downloaded from music stores), forming a personalized music playlist, and the decibel level is suitable for participants.

The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

Other Names:

• JS-502-A Intelligent and portable electroacupuncture
• apparatus(Han's low frequency neuromodulator, made in China)

Intervention Type: DEVICE

Donepezil hydrochloride tablets or carpalatine bitartrate tablets

① Donepezil hydrochloride tablets 5 mg, once a day, one tablet each time, before going to bed. The treatment period is 6 months.

② Carpalatine heavy tartrate tablets 1.5mg, 1 tablet/time 2 weeks before treatment, twice a day, breakfast and dinner with food, swallow. If there is no obvious adverse reaction after 2 weeks, the dosage can be increased to 2 tablets/time, twice a day. The treatment period is 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meeting the diagnostic criteria of SCD, MCI and mild dementia;
• Memory decline (self-reported or confirmed by both informants);
• Age 55-75 years;
• Memory impairment has not reached the diagnostic criteria of moderate and severe dementia;
• Hachinski ischemia scale score ≤ 4;
• Exclude any other systemic diseases that can cause brain dysfunction;
• Hamilton Depression Scale < 17;
• The subject or guardian signed the informed consent.

Exclusion Criteria

• There are advanced, serious or unstable other diseases, such as liver, kidney and other serious primary diseases;
• Severe hearing and visual impairment, can not cooperate with the assessment;
• with active epilepsy;
• Previous history of mental illness;
• Moderate or severe dementia, cerebral infarction or any physical or mental disorder that may lead to brain dysfunction;
• Having used other drugs that may cause cognitive function changes or heart, brain, kidney and other important organs failure before inclusion;
• Under 55 years old or above 75 years old;
• Unable to cooperate with the completion of the corresponding assessment and inspection and quit;
• Those who are likely to have poor compliance with the test;
• Participants in other subjects.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shaanxi Hospital of Traditional Chinese Medicine,

Xi'an, Shaanxi, China

Site Status: RECRUITING

Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, China

Site Status: NOT_YET_RECRUITING

Countries

China

Facility Contacts

Tongsheng Su, Master

Role: primary

Tongsheng Su, M.D

Role: primary

Other Identifiers

2020ZDLSF04-03

Identifier Type: -

Identifier Source: org_study_id