NCT01689246已完成3 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 891
- 试验地点
- 117
- 主要终点
- Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects 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 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of all cause dementia and probable Alzheimer's disease
- •Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score of 14-26 (inclusive)
- •Age < 90 years
- •Modified Hachinski ischemic score of ≤ 4
- •Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
- •Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
- •Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
- •If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
- •Able to comply with the study procedures
排除标准
- •Significant central nervous system (CNS) disorder other than Alzheimer's disease
- •Significant focal or vascular intracranial pathology seen on brain MRI scan
- •Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
- •Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders
- •Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
- •Resides in hospital or moderate to high dependency continuous care facility
- •History of swallowing difficulties
- •Pregnant or breastfeeding
- •Glucose-6-phosphate dehydrogenase deficiency
- •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
- •Preexisting or current signs or symptoms of respiratory failure
- •Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
- •Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
- •Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
- •Treatment currently or within 3 months before Baseline with any of the following medications:
- •Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
- •Carbamazepine, primidone
- •Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses
- •Current or prior participation in a clinical trial as follows:
- •Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
- •A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline
研究组 & 干预措施
TRx0237 250 mg/day
Experimental
干预措施: TRx0237 250 mg/day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TRx0237 150 mg/day
Experimental
干预措施: TRx0237 150 mg/day (Drug)
结局指标
主要结局
Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
时间窗: 65 weeks
Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
时间窗: 65 weeks
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
时间窗: 65 weeks
Safety parameters include adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, potential for suicide and self-harm, brain magnetic resonance imaging (MRI), and potential for serotonin toxicity
次要结局
- Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)(65 weeks)
- Change from Baseline on Mini-Mental Status Examination (MMSE)(65 weeks)
- Change in expected decline of whole brain volume as measured by brain MRI(39 weeks and 65 weeks)
研究者
研究点 (117)
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