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

NCT ID: NCT02759159

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AD-true acupuncture

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

Group Type EXPERIMENTAL

true acupuncture

Intervention Type PROCEDURE

acupuncture at the "four-gate"acupoints, three times per week and last for 6 months

AD-sham acupuncture

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

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type PROCEDURE

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

Mild Cognitive Impairment(MCI)-true acupuncture

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

Group Type EXPERIMENTAL

true acupuncture

Intervention Type PROCEDURE

acupuncture at the "four-gate"acupoints, three times per week and last for 6 months

MCI-sham acupuncture

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

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type PROCEDURE

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

Interventions

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true acupuncture

acupuncture at the "four-gate"acupoints, three times per week and last for 6 months

Intervention Type PROCEDURE

sham acupuncture

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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likuncheng

Head of Radiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Dongfang Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Kuncheng Li, Doctor

Role: CONTACT

+861083198376

Hui Li

Role: CONTACT

+861083198376

Facility Contacts

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Hui Li

Role: primary

Ran Pang, Doctor

Role: primary

+8613693121651

Other Identifiers

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81471649

Identifier Type: -

Identifier Source: org_study_id

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