A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease

Genentech, Inc.0 个研究点目标入组 56 人开始时间: 2008年8月最近更新: 2010年10月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Genentech, Inc.
入组人数: 56
主要终点: Safety and tolerability of single and multiple doses of MABT5102A

研究概览研究设计入排标准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

This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.

研究设计

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

入排标准

年龄范围: 50 Years 至 86 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of probable AD according to the NINCDS-ADRDA Criteria
•Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening
•Other prescription medications must be stable for ≥ 1 month prior to screening

排除标准

•Female patients with reproductive potential
•History or presence of any clinically significant CNS disease
•History of treatment with any protein therapeutic targeting Abeta

结局指标

主要结局

Safety and tolerability of single and multiple doses of MABT5102A

时间窗: Through study completion or early study discontinuation

次要结局

Pharmacokinetics of MABT5102A after single and multiple doses(Through study completion or early study discontinuation)
Immunogenicity of MABT5102A after single and multiple doses(Through study completion or early study discontinuation)

研究者

发起方

Genentech, Inc.

申办方类型

Industry

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