NCT01602393已完成2 期
A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patient With Mild Cognitive Impairment
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
- •Mini-Mental State Examination score higher than 24 at screening.
- •MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
排除标准
- •Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
- •Any medical condition that could explain the patients cognitive deficits.
- •CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
- •MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
- •Geriatric Depression Scale (30-point scale) score > 9 at screening.
- •History of stroke.
- •Modified Hachinski ischemic scale score > 4 at screening.
- •Women of childbearing potential.
- •Vitamin B12 or folate deficiency.
- •Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
- •Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
- •Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
- •Concomitant use of memantine at dose > 20 mg/day.
- •Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
研究组 & 干预措施
CHF 5074 2x
Experimental
oral tablet, multidose
干预措施: CHF 5074 2x (Drug)
CHF 5074 1x
Experimental
oral tablet, multidose
干预措施: CHF 5074 1x (Drug)
CHF 5074 3x
Experimental
oral tablet, multidose
干预措施: CHF 5074 3x (Drug)
结局指标
主要结局
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
研究点 (5)
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