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Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease

RecruitingNAAges 50 Years - 85 YearsAllJian Pei,MD
NCT03810794 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Acupuncture
  • Donepezil
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Where

3 sites
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, China
Huashan Hospital Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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