临床试验/NCT00479219

NCT00479219已完成1 期

A Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 in Blood and Cerebrospinal Fluid, When Administered Orally to Healthy Young Subjects and Patients With Alzheimer Disease

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 17 人开始时间: 2007年5月最近更新: 2008年7月10日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 17
主要终点: We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs.
•For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)

排除标准

未提供

研究组 & 干预措施

A

Experimental

干预措施: GSI-953 (Drug)

B

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.

时间窗: 5 months

次要结局

未报告次要终点

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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