NCT01548430已完成1 期
A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Number of participant with adverse events
研究概览
简要总结
The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 50 years of age.
- •Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
- •Weight ≥ 50 kg.
- •Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.
- •Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.
排除标准
- •Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.
- •Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.
研究组 & 干预措施
TTP4000 1.0 mg/kg
Experimental
Administered subcutaneously
干预措施: TTP4000 (Drug)
TTP4000 3.0 mg/kg
Experimental
Administered subcutaneously
干预措施: TTP4000 (Drug)
Placebo
Placebo Comparator
Administered subcutaneously
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participant with adverse events
时间窗: Day 0 to Day 84
次要结局
- Evaluation of participant plasma TTP4000 concentrations(Day 0 to Day 84)
研究者
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