Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Acupuncture
- 疾病 / 适应症
- Alzheimer Disease
- 发起方
- Jian Pei,MD
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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 certification scale. Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are 3 sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically. Participants in the control group will take donepezil only. A follow-up will be conducted 24 weeks after the treatment. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12. The secondary outcomes contains The change from baseline in MMSE score, ADCS-ADL score, QOL-AD score measured at weeks 12, 24 and 36.
研究者
Jian Pei,MD
Department Chief
Shanghai University of Traditional Chinese Medicine
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acupuncture Treatment Group
Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Acupuncture
Acupuncture Treatment Group
Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Donepezil
Donepezil Group
Participants in this group will be given only donepezil for 12 weeks.
干预措施: Donepezil
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
时间窗: Baseline(week -2), treatment at week 12
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
次要结局
- fractional amplitude of low frequency fluctuation (fALFF)(Baseline(week -2), Treatment at week 12)
- Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)(Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.)
- functional connectivity (FC)(Baseline(week -2), Treatment at week 12)
- Minimum Mental State Examination(MMSE)(Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.)
- Quality of Life-Alzheimer's Disease(QOL-AD)(Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.)