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Construction of a Brain Iron Metabolism Heterogeneity Atlas in Alzheimer's Disease and Mining of Personalized Therapeutic Targets for Jin's Three-Needle Therapy: A Randomized Controlled Trial

Construction of a Brain Iron Metabolism Heterogeneity Atlas in Alzheimer's Disease and Mining of Personalized Therapeutic Targets for Jin's Three-Needle Therapy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001662
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Alzheimers disease

Interventions

Experimental Group:Jin's three-needle
Control Group:sham acupuncture
Healthy Control Group:Non-interference

Sponsors

Southern Medical University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: I. Inclusion criteria for patients with mild to moderate AD: 1. Meet the clinical diagnostic criteria and symptom staging criteria for mild to moderate Alzheimer's disease; 2. Age 50–80 years, gender; 3. Have not received acupuncture treatment in the past six months; 4. CDR score is 1–2 points; 5. MoCA score is 10–20 points; 6. Able to cooperate with physicians to complete assessments and treatments as required by the study; 7. The subject and their legal representative understand the content of the study and sign a written informed consent form; 8. The subject is able to manage their daily life or is completely self-sufficient; if unable to manage independently, there must be a relatively fixed caregiver who can cooperate with the subject in receiving treatment and follow-up. II. Inclusion criteria for healthy controls: 1. Age 50–80 years, gender; 2. No main complaints of memory impairment and related clinical manifestations; 3. No cognitive decline, CDR = 0; 4. Overall good health, no neurological diseases; 5. Able to cooperate in completing various examinations and assessments; 6. Voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: I. Exclusion Criteria for Patients with Mild-to-Moderate Alzheimer's Disease (AD) 1. Dementia caused by systemic or neurological diseases, including Parkinson's disease, vascular dementia, Huntington's disease, normal-pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, chronic subdural hematoma, and multiple sclerosis; or a history of severe head trauma with persistent neurological deficits or known structural brain abnormalities. 2. Diagnosis of major depressive disorder or other serious psychiatric disorders. 3. History of previous psychoactive substance abuse or alcohol dependence that may interfere with cognitive function assessment. 4. Current participation in other interventional clinical research trials. 5. Acute neurological disorders (e.g., acute cerebrovascular events, encephalitis, traumatic brain injury), severe cardiac, hepatic, pulmonary, renal, or other systemic diseases, acute-phase infections, or malignant tumors. 6. Conditions that affect clinical evaluation, including aphasia, severe visual or auditory impairment, severe dysarthria, etc. 7. Presence of cardiac pacemaker, coronary stent, cochlear implant, or other ferromagnetic materials. 8. Contraindications to MRI, e.g., claustrophobia. 9. Withdrawal from the study during the course of the trial. 10. Any other severe disease that, in the investigator's judgment, may interfere with the study procedures. II. Exclusion Criteria for Healthy Controls 1. Clear clinical evidence of memory impairment or dementia, or a confirmed diagnosis of any type of dementia. 2. Other neurological disorders that may affect cognitive function, such as Parkinson's disease, brain tumor, epilepsy, sequelae of severe head trauma, history of intracranial infection, multiple sclerosis, etc. 3. Severe or unstable psychiatric disorders, such as major depressive disorder, schizophrenia, bipolar disorder, etc. 4. Long-term history of psychoactive substance abuse or alcohol dependence. 5. Severe or unstable systemic diseases involving the heart, liver, lung, kidney, or hematopoietic system, or malignant tumors. 6. Any contraindications to magnetic resonance imaging, e.g., ferromagnetic implants including cardiac pacemaker, defibrillator, aneurysm clip, cochlear implant, metallic prosthesis, etc.; or claustrophobia preventing successful scan completion. 7. Severe visual, auditory, or speech impairments that preclude cooperation with assessment and testing. 8. Current participation in other interventional clinical studies that may affect the results of this study. 9. Any other disease or condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment ;Alzheimer's Disease Assessment Scale Cognitive Subscale ;

Secondary

MeasureTime frame
Modified Barthel Index;Clinical Dementia Rating;Boston Naming Test;Digit Symbol Substitution Test;Wechsler Memory Scale;Neuropsychiatric Inventory;Alzheimer's Disease Collaborative Research - Activities of Daily Living ;Alzheimer's Disease Collaborative Study – Clinical Global Impression of Change ;Structural Magnetic Resonance Imaging;Quantitative Susceptibility Mapping;Functional Magnetic Resonance Imaging;

Countries

China

Contacts

Public ContactXu Mingzhu

Southern Medical University Shenzhen Hospital

xulcui123@126.com15019495393

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026