NCT04314934已完成2 期
Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
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
- 300
- 试验地点
- 33
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.
详细描述
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
- •Participants may be either outpatients, or residents of an assisted-living facility.
- •Participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
- •No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- •Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.
排除标准
- •Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
- •Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
- •Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
- •Any known hypersensitivity to any of the excipients contained in the study drug formulation.
研究组 & 干预措施
Active
Experimental
ANAVEX2-73
干预措施: ANAVEX2-73 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
时间窗: 96 weeks
To continue assessing the safety and tolerability of ANAVEX2-73
次要结局
- ADCS-ADL (Activities of Daily Living)(96 weeks)
- ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)(96 weeks)
研究者
研究点 (33)
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