Clinical trial NCT05641480: Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management
Official title: Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Subjective Cognitive Decline
Mild Cognitive Impairment
Mild Dementia
Keywords: Alzheimer's Disease
Subjective Cognitive Decline
Mild Cognitive Impairment
Mild Dementia
Lead sponsor: Shaanxi Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AD-seeds protein analyzer（Developed by Professor Jia Jianping of Capital Medical University of China）
timeFrame: Change from Baseline Aβ level at 6 months
measure: Or adopting Serum Aβ level is detected
timeFrame: Change from Baseline Aβ level at 6 months
Secondary outcomes:
measure: Electrocardiogram（ECG）
timeFrame: Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）
measure: Change of total MMSE score from baseline
timeFrame: 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）
measure: Montreal Cognitive Assessment Scale (MoCA) Score
timeFrame: 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）
measure: Disease conversion rate A
timeFrame: Baseline，6 months
measure: Disease conversion rate B
timeFrame: Baseline，6 months
measure: Disease conversion rate C
timeFrame: Baseline，6 months
measure: Disease conversion rate D
timeFrame: Baseline，6 months
measure: Disease conversion rate E
timeFrame: Baseline，6 months
measure: Disease conversion rate F
timeFrame: Baseline，6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Hospital of Traditional Chinese Medicine,
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Hospital of Traditional Chinese Medicine
state: Shaanxi
Study officials:
References: