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

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Procedure: true acupuncture; Procedure: sham acupuncture

• Registration Number: NCT02759159
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Study Start: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-true acupuncture	true acupuncture	True acupuncture at the "four-gate"acupoints will be administered on AD patients
AD-sham acupuncture	sham acupuncture	Sham acupuncture at the "four-gate"acupoints will be administered on AD patients
Mild Cognitive Impairment(MCI)-true acupuncture	true acupuncture	True acupuncture at the "four-gate"acupoints will be administered on MCI patients
MCI-sham acupuncture	sham acupuncture	Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients

Primary Outcome Measures

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

Trial Locations

Locations (2)

Xuanwu hospital; 🇨🇳 Beijing, Beijing, China

Dongfang Hospital,Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China