Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 1,600
- 主要终点
- Cognition and activities of daily living
研究概览
简要总结
The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.
详细描述
This trial is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of MPC-7869 to placebo. The study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.
The primary objective of the study is to evaluate the change in cognition and activities of daily living.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a diagnosis of probable Alzheimer's disease.
- •Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
- •Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
- •Ability to read and understand English or Spanish to ensure compliance with cognitive testing and study visit procedures.
- •Female subjects must be surgically sterile or postmenopausal for > 1 year.
- •Subjects currently taking approved medication for Alzheimer's disease for at least six months prior to day 1 may be enrolled.
- •Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.
排除标准
- •Current evidence of other causes of dementia.
- •History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
- •Chronic or acute renal, hepatic or metabolic disorder.
- •Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
- •Major surgery and related complications not resolved within 12 weeks prior to Day 1.
研究组 & 干预措施
1
800 mg BID
干预措施: MPC-7869 (Drug)
2
BID dosing
干预措施: MPC-7869 (Drug)
结局指标
主要结局
Cognition and activities of daily living
时间窗: 18 mos
次要结局
- Global function and behavior(18 mos)