Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
1 other identifier
interventional
180
1 country
3
Brief Summary
The objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale. In this 12-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with Donepezil, a total of 180 patients with Alzheimer's disease will be recruited. The patients will be randomly assigned to acupuncture combined with Donepezil (n =90) or Donepezil treatment (n =90). (36 sessions, 3 sessions a week). Changes in the cognition over time measured using ADAS-cog is the primary outcome. MMSE, ADCS-ADL and QOL-AD are the secondary outcomes. The study will be conducted at LongHua Hospital Shanghai University of Traditional Chinese Medicine, Huashan Hospital Fudan University, and Mental Health Center Shanghai Jiao Tong University School of Medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Mar 2019
Longer than P75 for not_applicable alzheimer-disease
3 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
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 22, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
January 6, 2026
January 1, 2026
7.8 years
January 17, 2019
January 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
Baseline(week -2), treatment at week 12
Secondary Outcomes (5)
Minimum Mental State Examination(MMSE)
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Quality of Life-Alzheimer's Disease(QOL-AD)
Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
fractional amplitude of low frequency fluctuation (fALFF)
Baseline(week -2), Treatment at week 12
functional connectivity (FC)
Baseline(week -2), Treatment at week 12
Study Arms (2)
Acupuncture Treatment Group
EXPERIMENTALParticipants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.
Donepezil Group
ACTIVE COMPARATORParticipants in this group will be given only donepezil for 12 weeks.
Interventions
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 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
Eligibility Criteria
You may qualify if:
- aged between 50-85 years
- 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
You may not qualify if:
- cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression))
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian Pei,MDlead
- Shanghai Mental Health Centercollaborator
- Huashan Hospitalcollaborator
Study Sites (3)
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Related Publications (2)
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.
PMID: 35986297DERIVEDZhan 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.
PMID: 35899271DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian Pei, Doctor
Shanghai University of Traditional Chinese Medicine
- STUDY DIRECTOR
Houguang Zhou, Doctor
Huashan Hospital
- STUDY DIRECTOR
Tao Wang, Doctor
Mental Health Center Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department Chief
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 22, 2019
Study Start
March 1, 2019
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
January 6, 2026
Record last verified: 2026-01