NCT01723670撤回2 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- CERESPIR
- 主要终点
- To determine the effects on change from baseline on brain atrophy
研究概览
简要总结
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.
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
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
- •Diagnosis of amnestic Mild Cognitive Impairment.
- •Mini-Mental State Examination score higher than 24 at screening.
排除标准
- •Diagnosis of Alzheimer's disease.
- •Any medical condition that could explain the subject's cognitive deficits.
- •MRI scans having evidence of pre-specified brain abnormalities.
- •History of stroke.
- •Vitamin B12 or folate deficiency.
- •Skin cancers and any cancer that is being actively treated.
- •Diagnosis of schizophrenia or recurrent mood disorder.
- •Abnormal kidney function.
- •Concomitant use of any study prohibitive medication.
研究组 & 干预措施
CHF 5074 1x
Experimental
oral tablet, multidose
干预措施: CHF 5074 1x (Drug)
CHF 5074 2x
Experimental
oral tablet, multidose
干预措施: CHF 5074 2x (Drug)
Placebo
Placebo Comparator
placebo, oral tablet, multidose
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effects on change from baseline on brain atrophy
时间窗: pre-dose, Months 6, 12, 18, 24 and Washout
次要结局
- To determine the presence of other biomarkers of neuronal degeneration(Month 24)
研究者
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