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

NCT05641480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-12-13

No results posted yet for this study

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

Interventions

DEVICE

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)

DRUG

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.

Sponsors & Collaborators

  • Shaanxi Hospital of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2025-12-09
Completion
2025-12-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641480 on ClinicalTrials.gov