Evaluating acupuncture treatment for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness and safety of acupuncture combined with Donepezil in improving cognitive function, daily living abilities, and quality of life in patients with Alzheimer's disease. A total of 180 participants aged 50-85 with mild to moderate Alzheimer's will be randomly assigned to receive either acupuncture alongside Donepezil or Donepezil alone over a 12-week period. The primary outcome will be measured using the ADAS-cog scale, while secondary outcomes will include assessments of cognitive function and quality of life. The study will take place across multiple hospitals in Shanghai.

Why it matters

Who can join: the full rules

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

Where it's running

• LongHua Hospital Shanghai University of Traditional Chinese Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
  Shanghai, Shanghai Municipality, China Recruiting
• Huashan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jian Pei, Doctor
• Email: jianpei99@hotmail.com
• Phone: 00862164385700

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating acupuncture for Alzheimer's treatment in different genetic groups

  This study is testing if acupuncture can help people with mild-to-moderate Alzheimer's disease feel better, especially looking at how it works for those with and without a specific gene.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.