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

NCT05641480 | Unknown DMC

• 1 other identifier: 2020ZDLSF04-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• AD-seeds protein analyzer（Developed by Professor Jia Jianping of Capital Medical University of China）

  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.

  Change from Baseline Aβ level at 6 months

• Or adopting Serum Aβ level is detected

  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)

  Change from Baseline Aβ level at 6 months

Secondary Outcomes (9)

• Electrocardiogram（ECG）

  Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）

• 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）

• 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 A

  Baseline，6 months

• Disease conversion rate B

  Baseline，6 months

Study Arms (3)

Subjective cognitive decline group

EXPERIMENTAL

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.

Device: Transcutaneous electrical acupoint stimulation&Music therapy

Mild cognitive impairment group

EXPERIMENTAL

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.

Device: Transcutaneous electrical acupoint stimulation&Music therapy

Mild dementia group

EXPERIMENTAL

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

Drug: Donepezil hydrochloride tablets or carpalatine bitartrate tablets

Interventions

Transcutaneous electrical acupoint stimulation&Music therapy 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; Subjective cognitive decline group

Donepezil hydrochloride tablets or carpalatine bitartrate tablets 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.

Mild dementia group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shaanxi Hospital of Traditional Chinese Medicine: lead

Study Sites (2)

Shaanxi Hospital of Traditional Chinese Medicine,

Xi'an, Shaanxi, 710003, China

RECRUITING

Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710003, China

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 7, 2022
• Study Start: June 3, 2022
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (2)