Status:
RECRUITING
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
Lead Sponsor:
Jian Pei,MD
Collaborating Sponsors:
Shanghai Mental Health Center
Huashan Hospital
Conditions:
Alzheimer Disease
Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
NA
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 usin...
Detailed Description
Objective: 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03810794
Start Date
March 1 2019
End Date
December 30 2026
Last Update
January 6 2026
Active Locations (3)
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1
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200032
2
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai Municipality, China, 200032
3
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040