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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759159
Recruitment Status : Unknown
Verified October 2016 by likuncheng, Xuanwu Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
likuncheng, 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Procedure: true acupuncture Procedure: sham acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: AD-true acupuncture
True acupuncture at the "four-gate"acupoints will be administered on AD patients
Procedure: true acupuncture
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months

Sham Comparator: AD-sham acupuncture
Sham acupuncture at the "four-gate"acupoints will be administered on AD patients
Procedure: sham acupuncture
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months

Experimental: Mild Cognitive Impairment(MCI)-true acupuncture
True acupuncture at the "four-gate"acupoints will be administered on MCI patients
Procedure: true acupuncture
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months

Sham Comparator: MCI-sham acupuncture
Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients
Procedure: sham acupuncture
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months




Primary Outcome Measures :
  1. brain functional connectivity [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759159


Contacts
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Contact: Kuncheng Li, Doctor +861083198376 cjr.likuncheng@vip.163.com
Contact: Hui Li +861083198376 810009062@qq.com

Locations
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China, Beijing
Xuanwu hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Hui Li       810009062@qq.com   
Dongfang Hospital,Beijing University of Chinese Medicine Not yet recruiting
Beijing, Beijing, China
Contact: Ran Pang, Doctor    +8613693121651    pangrandf@163.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
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Responsible Party: likuncheng, Head of Radiology Department, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02759159    
Other Study ID Numbers: 81471649
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders