Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.
Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.
Participants will:
Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.
Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.
详细描述
This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Streitberger placebo needle will be used as sham acupuncture method to mask the paticipants. The outcome assessors will also be blind to the grouping.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 50-85 years
- •Diagnosed by the 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
- •Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
- •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
Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Acupuncture (Other)
Acupuncture Treatment
Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Donepezil (Drug)
Sham Acupuncture Treatment
Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Sham Acupuncture (Other)
Sham Acupuncture Treatment
Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks.
干预措施: Donepezil (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)
时间窗: Change from baseline to 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
- Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)(Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2))
- Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)(Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2))
- Quality of Life-Alzheimer's Disease(QOL-AD)(Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2))
研究者
ZhanYJ
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine