Alzheimer DiseaseNCT05641480
Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management
A study testing Transcutaneous electrical acupoint stimulation&Music therapy and Donepezil hydrochloride tablets or carpalatine bitartrate tablets in people with Alzheimer Disease and Subjective Cognitive Decline, run by Shaanxi Hospital of Traditional Chinese Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Subjective Cognitive Decline, Mild Cognitive Impairment
- What is being tested?
- Transcutaneous electrical acupoint stimulation&Music therapy and Donepezil hydrochloride tablets or carpalatine bitartrate tablets
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jun 2022to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shaanxi Hospital of Traditional Chinese Medicine,
Xi'an, Shaanxi, 710003
Tongsheng Su, Master, 02987231294, chinasuts@126.com
Chi Zhang, master
- Not yet recruiting
Shaanxi Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710003
Tongsheng Su, M.D, 008615929562568, chinasuts@126.com
Tong Sheng Su, M.D.
About this study
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.
Read the 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.
- Being tested
- Transcutaneous electrical acupoint stimulation&Music therapy, Donepezil hydrochloride tablets or carpalatine bitartrate tablets
- Keywords
- Alzheimer's Disease, Subjective Cognitive Decline, Mild Cognitive Impairment, Mild Dementia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulation&Music therapyDevice
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)
Donepezil hydrochloride tablets or carpalatine bitartrate tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Donepezil hydrochloride tablets or carpalatine bitartrate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Change from Baseline Aβ level at 6 months
Secondary outcomes (9)
Electrocardiogram（ECG）
ECG QT Interval.（Security Index）
Measured: Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）
Change of total MMSE score from baseline
MMSE score are commonly used for estimating the severity of cognitive impairment with maximum score of 30. The questions in this scale included orientation to time, orientation to place, attention and calculation, recall of three words and visual construction.It can comprehensively, accurately and rapidly reflect the degree of mental state and cognitive impairment of the subjects. To provide scientific basis for clinical psychological diagnosis, treatment and neuropsychological research.
Measured: 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
MoCA is an assessment tool used for rapid screening of abnormal cognitive function, including 11 examination items in 8 cognitive fields, with a total score of 30 points, among which a score ≥26 is considered as normal cognitive function. Its high sensitivity, covering important cognitive fields, short test time, suitable for clinical application. The MoCA scores of the two groups are recorded before and after treatment.
Measured: 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
The disease conversion rate is calculated to evaluate the application effect of this model in elderly people with cognitive dysfunction.The number of stable dementia cases is calculated according to the diagnostic criteria of dementia symptom staging.
Measured: Baseline，6 months
Disease conversion rate B
According to the diagnostic criteria of dementia symptom staging, the number of participants turned to normal is calculated.
Measured: Baseline，6 months
Disease conversion rate C
According to the diagnostic criteria of dementia symptom staging, the number of disease conversion cases is calculated.
Measured: Baseline，6 months
Disease conversion rate D
The conversion of SCD to MCI/ Alzheimer's disease is calculated according to the diagnostic criteria of dementia symptom staging.
Measured: Baseline，6 months
Disease conversion rate E
According to the diagnostic criteria of dementia symptom staging, MCI is converted to Alzheimer's disease.
Measured: Baseline，6 months
Disease conversion rate F
According to the diagnostic criteria of dementia symptom staging, the conversion rate of mild dementia to moderate to severe dementia is calculated.
Measured: Baseline，6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start3 Jun 2022
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641480
- Sponsor's protocol ID
- 2020ZDLSF04-03
- Status last verified
- Dec 2022
- First submitted
- 20 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management
- ClinicalTrials.gov ID
- NCT05641480
- Acronym / sponsor ID
- 2020ZDLSF04-03
- Keywords
- Alzheimer's Disease, Subjective Cognitive Decline, Mild Cognitive Impairment, Mild Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjective cognitive decline group | Experimental | Device: Transcutaneous electrical acupoint stimulation&Music therapyStudies 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. |
| Mild cognitive impairment group | Experimental | Device: Transcutaneous electrical acupoint stimulation&Music therapyStudies 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. |
| Mild dementia group | Experimental | Drug: Donepezil hydrochloride tablets or carpalatine bitartrate tabletsOn the basis of the above two treatment options, oral donepezil hydrochloride tablets or carpalatine heavy tartrate tablets should be added. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulation&Music therapyProcedure: 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) | Device | Mild cognitive impairment group, Subjective cognitive decline group |
| Donepezil hydrochloride tablets or carpalatine bitartrate tablets① 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. | Drug | Mild dementia group |
Primary outcome
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.
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)
9 secondary outcomes
Electrocardiogram（ECG）
Time frame: Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）
Change of total MMSE score from baseline
Time frame: 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
Time frame: 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
Time frame: Baseline，6 months
Disease conversion rate B
Time frame: Baseline，6 months
Disease conversion rate C
Time frame: Baseline，6 months
Disease conversion rate D
Time frame: Baseline，6 months
Disease conversion rate E
Time frame: Baseline，6 months
Disease conversion rate F
Time frame: Baseline，6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation&Music therapy and Donepezil hydrochloride tablets or carpalatine bitartrate tablets in people with Alzheimer Disease and Subjective Cognitive Decline, run by Shaanxi Hospital of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.