CopperProof-2: Prospective, Randomized, Double-Blind Placebo-Controlled Clinical Trial Comparing the Effects of a Novel Once-Daily Oral Zinc Cysteine Preparation on Zinc and Copper Parameters in Mild Cognitive Impairment and Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Biometal levels will be measured in serum by atomic absorption spectrometry
研究概览
简要总结
This trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger bioavailable amount of zinc than an FDA approved preparation of inorganic zinc acetate; and 2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better tolerated with significantly less gastrointestinal side effects than the zinc acetate capsules. The trial also tests the hypothesis that, after 6 months of once daily administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper. Additionally, subjects will perform tests of mental function,including the dementia rating scale, the Mini Mental Status Examination and the ADAS-cognitive performance test aimed at Alzheimer's status assessment. Tests will be administered at baseline, 3 and 6 months, and the performance results compared. Care-giver assessments will also be noted.
详细描述
This multi-center study aims to determine the pharmacokinetics and pharmacodynamics of a novel gastro-retentive, sustained-release zinc cysteine preparation on the blood and urine measures of copper and zinc balance in Alzheimer's disease and mild cognitive impairment. Data expected to be derived include tolerability of the novel preparation in comparison with oral inorganic zinc salt, and long-term effects on primarily blood-measured copper-zinc balance. The study design is that of a prospective, randomized, double blind placebo-controlled clinical trial, with a duration for individual subjects of 6 months. The study will be performed at a total of 3 sites, under the direction of a single principal investigator, with a sub-investigator. The statistical plan calls for a comparison of data from the two long-term parallel groups using ANOVA and other applicable techniques. In addition to blood parameters, mental function assessments obtained at baseline, 3 and 6 months will be evaluated statistically.
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, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease mild to moderate as diagnosed by standard clinical, functional and NINDA-ADRDA criteria
- •Mild cognitive impairment diagnosed by standard clinical, functional and NINDA-ADRDA criteria
- •All subjects able to swallow Tablets
- •Subjects taking copper or zinc containing supplements must have a 30-day wash out before starting study materials
- •Screening laboratory values either within normal limits or deemed not clinically significant by investigator
排除标准
- •Subjects or their study companions/care givers unable to give adequate informed consent
- •Presence of a disease or condition known to affect biometal homeostasis
- •Presence of psychosis, substance abuse or other major medical or neurological issues
- •Presence of vascular dementia
- •Clinically significant anemia at the time of the screening visit
- •Current use of a decoppering drug such as trientine or penicillamine
结局指标
主要结局
Biometal levels will be measured in serum by atomic absorption spectrometry
时间窗: 6 to 12 months
Active comparator material orally administered will be associated with better tolerability than oral zinc acetate, and will produce a reduction in serum non-ceruloplasmin bound copper levels and an elevation in serum zinc levels
次要结局
- Serum zinc levels after oral administration of two different zinc-containing compounds and placebo will be determined by atomic absorption spectrometry(3 months)
- Comparison of mental status functions at baseline, 3 and 6 months in active comparator versus placebo groups.(6 to 12 months)