NCT00380276终止3 期
Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Myrexis Inc.
- 入组人数
- 1,000
- 主要终点
- Primary Safety
研究概览
简要总结
Open-label treatment with MPC-7869 for participants in a previous randomized study.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in a previous MPC-7869 randomized protocol
- •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.
- •Female subjects must be surgically sterile or postmenopausal for > 1 year.
- •Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.
排除标准
- •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.
研究组 & 干预措施
Open Label Arm
Other
Treatment is open-label
干预措施: MPC-7869 (Drug)
结局指标
主要结局
Primary Safety
时间窗: For study duration
次要结局
未报告次要终点
研究者
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