Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
NCT ID: NCT03810794
Last Updated: 2026-01-06
Study Results
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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RECRUITING
NA
180 participants
INTERVENTIONAL
2019-03-01
2026-12-30
Brief Summary
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Detailed Description
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Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are 3 sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically. Participants in the control group will take donepezil only. A follow-up will be conducted 24 weeks after the treatment. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12. The secondary outcomes contains The change from baseline in MMSE score, ADCS-ADL score, QOL-AD score measured at weeks 12, 24 and 36.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture Treatment Group
Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.
Acupuncture
The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.
Donepezil
Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
Donepezil Group
Participants in this group will be given only donepezil for 12 weeks.
Donepezil
Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
Interventions
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Acupuncture
The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.
Donepezil
Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
* cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
* magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
* the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
* voluntarily joining this study with informed consents
Exclusion Criteria
* a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
* aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
* anticoagulant treatments such as warfarin or heparin
* use of pacemakers or receiving acupuncture in the past 2 weeks
50 Years
85 Years
ALL
Yes
Sponsors
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Shanghai Mental Health Center
OTHER
Huashan Hospital
OTHER
Jian Pei,MD
OTHER
Responsible Party
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Jian Pei,MD
Department Chief
Principal Investigators
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Jian Pei, Doctor
Role: STUDY_CHAIR
Shanghai University of Traditional Chinese Medicine
Houguang Zhou, Doctor
Role: STUDY_DIRECTOR
Huashan Hospital
Tao Wang, Doctor
Role: STUDY_DIRECTOR
Mental Health Center Shanghai Jiao Tong University School of Medicine
Locations
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LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Tao Wang, Doctor
Role: primary
Houguang Zhou, Doctor
Role: primary
References
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Fu QH, Pei J, Zhou HG, Wang T, Zhan YJ, Tao L, Xu J, Zhou Q, Wang LY. Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial. Trials. 2022 Aug 19;23(1):695. doi: 10.1186/s13063-022-06532-1.
Zhan Y, Fu Q, Pei J, Fan M, Yu Q, Guo M, Zhou H, Wang T, Wang L, Chen Y. Modulation of Brain Activity and Functional Connectivity by Acupuncture Combined With Donepezil on Mild-to-Moderate Alzheimer's Disease: A Neuroimaging Pilot Study. Front Neurol. 2022 Jul 11;13:912923. doi: 10.3389/fneur.2022.912923. eCollection 2022.
Other Identifiers
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18401970500
Identifier Type: -
Identifier Source: org_study_id
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