Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
研究概览
简要总结
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
详细描述
Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
- •Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score
排除标准
- •Dementia due to other causes
- •Evidence of a clinically relevant or unstable psychiatric disorder
- •Has irritable bowel syndrome or inflammatory bowel disease
- •Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
- •Has visual or hearing disorder, defeating completion of evaluation
- •Use of AD therapy (except for donepezil hydrochloride) which cannot be stopped
- •Use of antibiotics within 1 month prior to enrollment
- •Has a history of gastrointestinal surgery (except for appendicitis and hernia surgery)
- •Without a reliable caregiver who will accompany the participant during treatment and assessment, and monitor administration of the prescribed medications
- •With cardiac pacemaker or metal allergy
- •Once experienced electroacupuncture treatment before at any time (manual acupuncture is allowed)
- •Premenopausal woman
研究组 & 干预措施
Active acupuncture + Donepezil
Active acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride
干预措施: Active acupuncture (Device)
Active acupuncture + Donepezil
Active acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride
干预措施: Donepezil Hydrochloride (Drug)
Sham acupuncture + Donepezil
Sham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride
干预措施: Sham acupuncture (Device)
Sham acupuncture + Donepezil
Sham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride
干预措施: Donepezil Hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
时间窗: Baseline, Week 7, Week 14, Week 21, Week 28
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 12 items (ranges from 0 to 75). Higher scores indicating greater cognitive impairment.
次要结局
- Change From Baseline in Mini-Mental State Examination (MMSE)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Change From Baseline in Neuropsychiatric Inventory (NPI)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Change From Baseline in Mini-Mental State Examination (MMSE)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Change From Baseline in Neuropsychiatric Inventory (NPI)(Baseline, Week 7, Week 14, Week 21, Week 28)
- Treatment credibility(Week 1, Week 14)
- Incidence of adverse events(Week -4 to Week 28)
- Change in gut microbiota diversity based on 16S rRNA gene sequencing analysis(Baseline, Week 14, Week 28)