Evaluating acupuncture treatment for Alzheimer's disease
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
This study is testing if adding acupuncture to the usual Alzheimer's medication can help improve thinking skills and quality of life for people with mild to moderate Alzheimer's.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Shanghai University of Traditional Chinese Medicine Academic / other |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT03810794 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-85 diagnosed with mild to moderate Alzheimer's disease.
Not a fit: Patients with cognitive impairment due to other factors, such as vascular dementia or metabolic abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance cognitive function and quality of life for patients with Alzheimer's disease.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific combination with Donepezil for Alzheimer's is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.