NCT03810794Recruiting
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 17 Jan 2019
- Start date
- 1 Mar 2019
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Jian Pei,MD
- Diseases
- Alzheimer disease
- NCT number
- NCT03810794
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Mar 2019 to the primary completion date, 30 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of pacemakers or receiving acupuncture in the past 2 weeks
Other illness
- 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
Other
- anticoagulant treatments such as warfarin or heparin
Who the study is looking for
- 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
Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| LongHua Hospital Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Mental Center, Shanghai Jiaotong University of Medicial School Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.