NCT00322036终止3 期
Phase 3 Multinational, 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
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
- 800
- 主要终点
- Cognition and activities of daily living
研究概览
简要总结
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.
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 greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
- •Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
- •Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
- •At least 6 years of education, or sufficient work history to exclude mental retardation.
- •Female subjects must be surgically sterile or postmenopausal for > 1 year.
- •Adequate vision and hearing to participate in study assessments.
- •Subjects must have a reliable caregiver who can read, understand and speak same language.
排除标准
- •Current evidence of other causes of dementia.. .
- •History of, 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.
- •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
- •Previous participation in an MPC-7869 clinical study.
研究组 & 干预措施
1
Experimental
Oral 800 mg BID dosing
干预措施: MPC-7869 (Drug)
2
Placebo Comparator
Oral 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 cognition(18 months)
研究者
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