Actively Recruiting
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
Led by Jian Pei,MD · Updated on 2026-01-06
180
Participants Needed
3
Research Sites
408 weeks
Total Duration
On this page
Sponsors
J
Jian Pei,MD
Lead Sponsor
S
Shanghai Mental Health Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 50 and 85 years
- Diagnosed according to Neurological Communicative Disorders and Stroke and Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Mild to moderate Alzheimer's disease based on Chinese Mini Mental State Examination (MMSE) scores (11 to 22 for primary school degree; 11 to 26 for junior high school degree or above)
- MRI confirmation of hippocampus or medial temporal lobe atrophy indicating high possibility of Alzheimer's disease
- Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score of 2 or higher if under 75 years, or 3 or higher if over 75 years
- Willing to join the study with informed consent
You will not qualify if you...
- Cognitive impairment caused by other factors like vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, vitamin deficiencies, delirium, or other mental disorders such as schizophrenia or depression
- Serious heart, liver, kidney, or blood system diseases, or whole-body malnutrition
- Aphasia, consciousness disturbance, or inability to cooperate with examinations due to physical disability
- Receiving anticoagulant treatments such as warfarin or heparin
- Use of pacemakers or acupuncture treatment within the past 2 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
J
Jian Pei, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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