NCT01626391终止2 期
A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Significant central nervous system disorder other than Alzheimer's disease
- •Patients in whom baseline MRI is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant
- •Significant focal or intracranial pathology that would lead to a diagnosis other than probable Alzheimer's disease
- •Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness
- •Major depressive disorder, schizophrenia or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
- •Resides in a hospital or continuous care facility
- •History of swallowing difficulties
- •Pregnant or breastfeeding
- •History of significant hematological abnormality or current acute or chronic clinically significant abnormality
- •Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
- •Clinically significant cardiovascular disease or abnormal assessments
- •Pre-existing or current signs or symptoms of respiratory failure
- •Concurrent acute or chronic clinically significant immunologic, renal, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
- •Prior intolerance to methylthioninium-containing drug or any of the excipients
- •Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):
- •Anxiolytics and/or sedatives/hypnotics (exceptions: sedation for MRI or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime)
- •Antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone)
- •Carbamazepine
- •Drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials, sulfonamides)
- •Warfarin (and other Coumadin derivates such as phenprocoumon)
- •Current or prior participation in a clinical trial of a drug, biologic, or device in which the last dose was received within 28 days prior to Baseline
研究组 & 干预措施
TRx0237
Experimental
干预措施: TRx0237 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
时间窗: 8 weeks
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
次要结局
未报告次要终点
研究者
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