The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI

Study Overview
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Brief Summary
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Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity.

Official Title
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The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the Four-gate Acupoints

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Procedure: true acupuncture
* Procedure: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly Exclusion Criteria: Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD-true acupuncture<br>True acupuncture at the four-gateacupoints will be administered on AD patients | Procedure: true acupuncture<br>* acupuncture at the four-gateacupoints, three times per week and last for 6 months<br>|
| Sham Comparator: AD-sham acupuncture<br>Sham acupuncture at the four-gateacupoints will be administered on AD patients | Procedure: sham acupuncture<br>* acupuncture at the places 1cm from the true four-gate acupoints,three times per week and last for 6 months<br>|
| Experimental: Mild Cognitive Impairment(MCI)-true acupuncture<br>True acupuncture at the four-gateacupoints will be administered on MCI patients | Procedure: true acupuncture<br>* acupuncture at the four-gateacupoints, three times per week and last for 6 months<br>|
| Sham Comparator: MCI-sham acupuncture<br>Sham acupuncture at the four-gateacupoints will be administered on MCI patients | Procedure: sham acupuncture<br>* acupuncture at the places 1cm from the true four-gate acupoints,three times per week and last for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain functional connectivity | GE750 3.0T gradient-echo single-shot echo plannar imaging TR=2000ms TE=30ms slice=36 slice thickness=3mm gap=1mm volumes=180 | with in first week after the whole acupuncture treatment |