NCT00203359已完成1 期
Etanercept for Alzheimer's-Type Memory Loss Pilot Study
Tobinick, Edward Lewis, M.D.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- MMSE
研究概览
简要总结
It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.
详细描述
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NINCDS-ADRDA Criteria for Alzheimer's disease
- •CT or MRI consistent with AD
排除标准
- •active infection
- •demyelinating disease
- •uncontrolled diabetes mellitus
- •vascular dementia
- •clinically significant neurologic disease other than AD
- •Hachinski >4
- •history of lymphoma
- •wbc<2500
- •platelets<100,000
- •pregnancy
- •premenopausal, fertile not on acceptable birth control
- •change in neuroactive medication within 4 weeks of study initiation
结局指标
主要结局
MMSE
ADAS-Cog
SIB
次要结局
- other neuropsychological tests
- Category fluency
研究者
研究点 (2)
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