NCT01424436已完成1 期
Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
研究概览
简要总结
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
详细描述
This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
- •Increase in total tau or p-tau in CSF
- •Decrease in amyloid beta in CSF
- •Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
- •Body weight less than 120 kg
- •Willingness to comply with contraceptive methods if self or partner is of child-bearing potential
排除标准
- •Any other cause of dementia
- •Other significant neurologic or psychiatric illness
- •Hachinski Ischemia Score >4
- •More than 3 microbleeds on MRI
- •Type 2 diabetes not controlled by diet
- •Risk of cerebrovascular disease, cerebral haemorrhage or stroke
- •History of systemic autoimmune disease
- •Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)
- •Use of chronic corticosteroids
- •Uncontrolled hypertension in spite of antihypertensive medications
- •Renal or hepatic insufficiency or clinically significant anaemia
- •In nursing home care
- •Contraindications to lumbar puncture or MRI
- •Prior participation in therapeutic studies only after adequate wash-out period
结局指标
主要结局
The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
时间窗: 22 hours
To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours
次要结局
- The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment(Two months)
- Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.(three months)
- To assess the safety and tolerability after single dose of GSK933776 administration.(three months)
- The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment(22 hours)
研究者
研究点 (8)
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