NCT01669876终止2 期
3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of subjects experiencing adverse effects when using the supplement
研究概览
简要总结
To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 65 years old.
- •Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
- •Score 16 or more on the Mini-Mental State Examination (MMSE).
- •Otherwise stable medical history and general health.
- •Weigh between 45 kg and 120 kg inclusive.
排除标准
- •Have contra-indications, allergy, or sensitivity to the study products or their components.
- •Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab).
- •Be a current smoker or smokeless tobacco user.
结局指标
主要结局
Number of subjects experiencing adverse effects when using the supplement
时间窗: 3 months
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
次要结局
- Measured changes in blood markers of AD(3 months)
- Changes in global or functional measures of AD in subjects during the course of the study(3 months)
研究者
研究点 (2)
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