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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
true acupuncture
sham acupuncture
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu hospitalRecruiting
  • Dongfang Hospital,Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

AD-true acupuncture

AD-sham acupuncture

Mild Cognitive Impairment(MCI)-true acupuncture

MCI-sham acupuncture

Arm Description

True acupuncture at the "four-gate"acupoints will be administered on AD patients

Sham acupuncture at the "four-gate"acupoints will be administered on AD patients

True acupuncture at the "four-gate"acupoints will be administered on MCI patients

Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 14, 2016
Last Updated
October 4, 2016
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02759159
Brief Title
The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI
Official Title
The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AD-true acupuncture
Arm Type
Experimental
Arm Description
True acupuncture at the "four-gate"acupoints will be administered on AD patients
Arm Title
AD-sham acupuncture
Arm Type
Sham Comparator
Arm Description
Sham acupuncture at the "four-gate"acupoints will be administered on AD patients
Arm Title
Mild Cognitive Impairment(MCI)-true acupuncture
Arm Type
Experimental
Arm Description
True acupuncture at the "four-gate"acupoints will be administered on MCI patients
Arm Title
MCI-sham acupuncture
Arm Type
Sham Comparator
Arm Description
Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients
Intervention Type
Procedure
Intervention Name(s)
true acupuncture
Intervention Description
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months
Intervention Type
Procedure
Intervention Name(s)
sham acupuncture
Intervention Description
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months
Primary Outcome Measure Information:
Title
brain functional connectivity
Description
GE750 3.0T gradient-echo single-shot echo plannar imaging TR=2000ms TE=30ms slice=36 slice thickness=3mm gap=1mm volumes=180
Time Frame
with in first week after the whole acupuncture treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuncheng Li, Doctor
Phone
+861083198376
Email
cjr.likuncheng@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Li
Phone
+861083198376
Email
810009062@qq.com
Facility Information:
Facility Name
Xuanwu hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li
Email
810009062@qq.com
Facility Name
Dongfang Hospital,Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Pang, Doctor
Phone
+8613693121651
Email
pangrandf@163.com

12. IPD Sharing Statement

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

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