NCT01282619Unknown2 期
A Multi-Center, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Study to Evaluate the Safety and Efficacy of Huperzine A Sustained-Release Tablets in Patients With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale - Cognitive Subscale
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of Huperzine A sustained release tablets in patients with mild to moderate Alzheimer's Disease.
详细描述
The primary aim of this multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled therapeutic trial is to determine whether treatment with huperzine A sustained-release tablets can improve cognitive function in individuals with AD.
A total of 390 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A sustained-release tablets 400µg once a day, huperzine A tablets 200µg twice a day, and placebo.
The study is divided into 2 periods:
- A two-week placebo run-in period
- A 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patient aged between 50 and 85
- •Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria
- •Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;
- •CT or MRI scan excluding another structural brain disease;
- •Hachinski Ischemic Score < 4
- •Hamilton Depression Scale ≤10
- •Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
排除标准
- •Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
- •Epileptic Patient
- •Severe liver or renal disease
- •Resting pulse less than 50
- •Mechanical intestinal obstruction patient
- •History of stroke
- •History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease
- •Cognitive damage caused by alcohol or substance abuse
- •Disable to participate or cooperate in the protocol
- •Use of any agent for the treatment of dementia within 2 weeks of randomization
- •Use of another investigational agent within 3 months of screening
- •Be sensitive to Huperzine A or other ACHEIs.
研究组 & 干预措施
Huperzine A Sustained-Release Tablet
Experimental
干预措施: huperzine A (Drug)
Huperzine A Tablet
Active Comparator
干预措施: huperzine A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - Cognitive Subscale
时间窗: week 24
次要结局
- Clinician's Interview Based Impression of Change, plus caregiver input(week 24)
- Activities of Daily Living(week 24)
- Neuropsychiatric Inventory(week 24)
研究者
研究点 (1)
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