The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI
The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 5, 2016
October 1, 2016
2.5 years
April 14, 2016
October 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
AD-true acupuncture
EXPERIMENTALTrue acupuncture at the "four-gate"acupoints will be administered on AD patients
AD-sham acupuncture
SHAM COMPARATORSham acupuncture at the "four-gate"acupoints will be administered on AD patients
Mild Cognitive Impairment(MCI)-true acupuncture
EXPERIMENTALTrue acupuncture at the "four-gate"acupoints will be administered on MCI patients
MCI-sham acupuncture
SHAM COMPARATORSham acupuncture at the "four-gate"acupoints will be administered on MCI patients
Interventions
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly
You may not qualify if:
- Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xuanwu hospital
Beijing, Beijing Municipality, 100053, China
Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Radiology Department
Study Record Dates
First Submitted
April 14, 2016
First Posted
May 3, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 5, 2016
Record last verified: 2016-10