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Study for acupuncture on time and targeting regulation mechanism of aMCI brain functional network

Study for acupuncture on time and targeting regulation mechanism of aMCI brain functional network

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019898
Enrollment
Unknown
Registered
2018-12-07
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amnestic mild cognitive impairment

Interventions

Amnestic mild cognitive impairment group:acupuncture treatment
Normal population control group:none

Sponsors

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with amnestic mild cognitive impairment (1) The complaint of memory loss was confirmed by the person who knew it. The duration of symptoms was longer than 6 months; (2) Clinical evaluation confirmed cognitive impairment. Logical memory impairment such as Delayed Story Recall (DSR) score in memory-type cases was at least 1.5 SD lower than the average of age-or education-matched population; executive function or visual-spatial impairment in non-memory-type cases such as Clock Draw Test (CDT) Scores were 1.0 SD lower than the average level of age-matched or education-matched people; scores of language dysfunction such as Verbal Category Fluency Test (VCFT) were 1.0 SD lower than the average level of age-matched or education-matched people; and cognitive cases had at least two cognitive impairments, respectively 1.0SD lower, compared with age and education-matched people,and the severity could not meet the dementia standard; (3) Mini-mental State Examination (MMSE) scored between 24 and 30; (4) Clinical Dementia Rating (CDR) scored 0.5, and amnesia CDR scored at least 0.5; (5) The overall cognitive function was fully preserved, such as the score of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) between 11 and 17; (6) Activities of daily life are intact or very slightly impaired, such as Instrumental Activities of Daily Living (IADL) score greater than or equal to 16; (7) Older than 50 yeas, and right-handed; (8) Good vision and hearing to undergo neuropsychological tests; (9) Health, no use of drugs which can interference the test; (10) Sign the informed consent form, and the informed person (contacting the subjects regularly, averaging more than 10 hours a week) agrees to participate in the experimental study, observe the side effects and accompany the subjects to see a doctor during the experiment; (11) Drugs administered at least one month before screening include antidepressants with no significant anticholinergic side effects and stable doses (if the patient does not have a history of depression and major depression in the past two years), estrogen replacement therapy and ginkgo preparations (permissible, but not encouraged); (12) 12 months before aMCI screening, CT or magnetic resonance imaging (MRI) scans showed no evidence of infection, infarction or other focal lesions, and no related clinical symptoms, but allowed lacunar infarction in a non-critical brain region and was not considered to affect the cognitive impairment of the subjects; The score of the Hachinski Ischemia Scale HIS was less than or equal to 4; 2. Control group of normal population: (1) Aged 50-70 years old, Han nationality, right-handed, good health in general, no nervous system diseases; (2) Without complaints and clinical manifestations of memory impairment; (3) normal cognitive function, and the Mini-Mental State Examination scale (MMSE) more than 27 points; (4) The ADL less than 26 points; (5) Without cognitive impairment (clinical dementia scale (CDR) 0).

Exclusion criteria

Exclusion criteria: Patients with amnestic mild cognitive impairment 1. Any neurological disorder that causes dementia, including AD Parkinson's disease, VaD, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, with a history of severe head trauma and a history of persistent neurological deficits or known brain structural abnormalities; 2. Depression in the past two years, Hamilton Depression Rating Scale scores more than or equal to 12 points, or other mental disorders that meet the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Diseases; 3. There was a history of alcohol, drug abuse or dependence (DSM-IV) in the past two years; 4. Any significant systemic disease or unstable medical condition that may lead to difficulty in complying with the experimental design, including: (1) a history of cancer in the past five years (excluding metastatic skin cancer); and (2) a history of myocardial infarction, instability or severe cardiovascular disease, including symptomatic heart failure in angina pectoris or resting state; (3) clinically significant obstructive pulmonary disease or asthma; (4) clinically significant and unstable gastrointestinal diseases, such as gastric ulcer or a history of active or occult gastrointestinal bleeding in the past two years; (5) clinically significant laboratory abnormalities in a group of screening tests (hematology, prothrombin time, chemistry, urine test) _Type I diabetes mellitus or uncontrolled diabetes mellitus_uncontrolled hypertension (systolic pressure greater than 170 mmHg or diastolic pressure greater than 100 mmHg); _clinically significant history of liver disease, coagulation disorder or vitamin K deficiency in the past two years; 5. Drug therapy was used within 30 days before joining the study, including: (1) central receptor blockers, anesthetics, methyldopa and clonidine; (2) anti-Parkinson's disease drugs, such as levodopa, amantadine, bromoergic peptide, propylergoline and selegilin, were used within 2 months before screening; (3) neurosedatives and and Analgesics; (4) Benzodiazepines (diazepam) and barbiturates; (5) Short-acting anti-anxiety agents or sedative sleep hormones are used more than twice a week (no sedative should be used within 72 hours before screening); (6) Antidepressants without obvious cholinergic side effects are in dose change or effective period; (7) Hormones; (8) Drugs with obvious cholinergic or anticholinergic side effects (such as pyridostigmine, tricyclic antidepressants, chlorobenzoxazine, oxibnin); (9) Antiepileptic drugs (phenytoin sodium, phenobarbital, carbamazepine); (10) Warfarin (benzylacetone coumarin). 6. Any clinical trial drugs for AD or dementia, such as vitamin supplements (including vitamin E), multivitamins, donepezil hydrochloride, memantine hydrochloride and other recently approved drug therapies, were used within 30 days before the trial; 7. Subjects who the researchers believe cannot follow the research procedure.

Design outcomes

Primary

MeasureTime frame
clinical dementia rating;Boston naming test;Digital Color Connection Test;Wechsler Memory Scale;Instrumental daily living ability test;resting-state fMRI;

Secondary

MeasureTime frame
blood routine examination;urine routine examination;stool routine examination;liver function examination;kidney function examination;cardiogram;mini-mental state examination;Alzheimer Assessment scale;Hachinski ischemic scale;

Countries

China

Contacts

Public ContactShaoyang Cui

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

herb107@126.com+86 15112491899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026