Alzheimer's Disease
Conditions
Interventions
Acupuncture group:Sanjiao Acupuncture Method
Control Group:True acupoint, sham needle, does not penetrate.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Refer to the revised diagnostic and staging criteria for Alzheimer's disease (2024 edition) published by the National Institute on Aging and the Alzheimer's Association, and determine the clinical stage as mild to moderate dementia. 2) Age between 55 and 80 years, gender is unrestricted. 3) Mini-Mental State Examination (MMSE) score =24 and >10. 4) Clear consciousness, stable mood, able to perform simple reading, calculation, writing, and daily communication. 5) The subject voluntarily participates in the clinical study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Dementia caused by other reasons, such as stroke, Huntington's disease, frontotemporal lobar atrophy, or multiple system atrophy; 2) Those with cognitive impairment due to traumatic brain injury or other causes; 3) Those with severe systemic diseases, such as malignant tumors, immune system diseases, liver failure, kidney failure, or cardiopulmonary failure; 4) Those with severe neurological deficits, such as hemiplegia, epilepsy, aphasia, deafness, or blindness; 5) Those with mental disorders such as anxiety or depression, or those taking long-term psychiatric medications; 6) Those using medications related to cognitive function; 7) Those exposed to chemical toxins, severe viruses, or bacteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog);Activities of Daily Living Scale (ADL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring Scale ;Neuropsychological Scales (Auditory Verbal Learning Test - Huashan Version AVLT-H, Animal Fluency Test AFT, Boston Naming Test 30-item BNT-30, Digit Span Test DST, Shape Trail Test STT-A&B, Clock Drawing Test CDT);Zarit Burden Scale;Clinical Dementia Rating Scale (CDR);Serum immune indicators (IL-1ß, IL-6, TNF-a, IL-10);Serum biomarkers (Aß42, Aß40, p-Tau217, p-Tau181, NfL, GFAP);Gut microbiota diversity: OTU clustering analysis (Venn diagram, species abundance clustering heat map, species phylogenetic tree), a-diversity (Shannon index, Simpson index, Chao1 index, rarefaction curve, rank abundance curve), ß-diversity (distance matrix heat map, Principal Coordinates Analysis (PCoA), Non-Metric Multidimensional Scaling (NMDS)).;Gut microbiota metabolites: Trimethylamine N-oxide (TMAO), Short-chain fatty acids (SCFAs), Lipopolysaccharide (LPS);Brain Function Assessment: Near-Infrared Spectroscopy (fNIRS), Electroencephalogram (EEG), Functional Magnetic Resonance Imaging (fMRI).;Vagus Nerve Tonus Measurement: Heart Rate Variability Analysis; | — |
Countries
China
Contacts
Public ContactYu Tao
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed