Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management
Overview
- Phase
- Not Applicable
- Intervention
- Transcutaneous electrical acupoint stimulation&Music therapy
- Conditions
- Alzheimer Disease
- Sponsor
- Shaanxi Hospital of Traditional Chinese Medicine
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Or adopting Serum Aβ level is detected
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Transcutaneous electrical acupoint stimulation&Music therapy
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.
Intervention: Transcutaneous electrical acupoint stimulation&Music therapy
Mild dementia group
On the basis of the above two treatment options, oral donepezil hydrochloride tablets or carpalatine heavy tartrate tablets should be added.
Intervention: Donepezil hydrochloride tablets or carpalatine bitartrate tablets
Outcomes
Primary Outcomes
Or adopting Serum Aβ level is detected
Time Frame: Change from Baseline Aβ level at 6 months
A certain amount of fasting venous blood is collected from participants before and after treatment, and the supernatant is collected by low-speed centrifugation at a certain temperature. The serum Aβ level is detected by enzyme-linked immunosorbent assay (ELISA)
AD-seeds protein analyzer（Developed by Professor Jia Jianping of Capital Medical University of China）
Time Frame: Change from Baseline Aβ level at 6 months
The area under curve is used to show the ability of the AD-seeds-detector to diagnose AD. The value of area under curve is higher, then the ability of the AD-seeds-detector to diagnose AD is stronger.AD-seeds protein analyzer is an antibody-free and cost-efective approach for measuring blood biomarkers. It's a newly developed instrument to distinguish Alzheimer's disease (AD) from other forms of dementia.It examines amyloid in the blood. Alzheimer's disease is usually not discovered until the late stage, and early detection and intervention are of great significance to improve the treatment effect of the disease.
Secondary Outcomes
- Disease conversion rate E(Baseline，6 months)
- Disease conversion rate F(Baseline，6 months)
- Montreal Cognitive Assessment Scale (MoCA) Score(Change from Baseline at 6 months（FIve times：Week -1~0 day，Week 4 ± 2 days，week 8 ± 2 days，week 12 ± 3 days，week 24 ± 3 days）)
- Disease conversion rate C(Baseline，6 months)
- Disease conversion rate D(Baseline，6 months)
- Electrocardiogram（ECG）(Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）)
- Disease conversion rate B(Baseline，6 months)
- Change of total MMSE score from baseline(Change from Baseline at 6 months（FIve times：Week -1~0 day，Week 4 ± 2 days，week 8 ± 2 days，week 12 ± 3 days，week 24 ± 3 days）)
- Disease conversion rate A(Baseline，6 months)