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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02759159
• Other study ID #: 81471649
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2016
• Last updated: October 4, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Xuanwu Hospital, Beijing
• Contact: Kuncheng Li, Doctor
• Phone: +861083198376
• Email: cjr.likuncheng[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Procedure:
• true acupuncture
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months
• sham acupuncture
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months

Locations

Country	Name	City	State
China	Dongfang Hospital,Beijing University of Chinese Medicine	Beijing	Beijing
China	Xuanwu hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No