NCT00684944已完成2 期
An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 主要终点
- Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
研究概览
简要总结
This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
- •Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
- •The patient must have been ongoing in TRx-014-001 at time of study termination.
排除标准
- •There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.
研究组 & 干预措施
1
Active Comparator
30mg tid TRx0014
干预措施: TRx0014 (Drug)
2
Active Comparator
60mg tid TRx0014
干预措施: TRx0014 (Drug)
结局指标
主要结局
Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
时间窗: 0, 26 and 52 weeks
次要结局
- Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).(0, 26 and 52 weeks)
- Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)(0, 26 and 52 weeks)
研究者
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