A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
详细描述
This Phase II study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Subjects will be randomly assigned to the Group I arm (ALZT-OP1a adjuvant treatment), which will consist of ALZT-OP1a for inhalation, taken twice daily (morning and evening), OR the Group II placebo arm, which will consist of inhaled placebo, taken twice daily (morning and evening).
A minimum of 350 subjects will be randomized to receive one of two possible treatment assignments: ALZT-OP1a adjuvant treatment of active study drug or placebo.
To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 500 (or 250 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 175 evaluable subjects per treatment arm.
Randomization assignments will be stratified by site to ensure balance by site.
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
- 18 Years 至 —（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
- •Subject has medical history of dementia (prior to current ischemic stroke event);
- •Subject has a known medical history of major depression or psychotic disorder;
- •Unstable cardiovascular or cerebrovascular disease;
- •Aphasia or other disability severe enough to prevent valid neuropsychiatric assessment;
- •History of any other significant neurological disease prior to ischemic stroke;
- •History of schizophrenia or bipolar disorder (DSM-IV criteria);
- •History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria);
- •Currently taking medications that could lead to difficulty complying with the protocol;
- •Investigational agents are prohibited one month prior to entry and for the duration of the trial;
- •Currently taking cromolyn, or has taken cromolyn, within the past 12 months;
- •Allergy to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.);
- •Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs (examples: Stage III-IV chronic obstructive pulmonary disease [COPD], emphysema);
- •Uncontrolled chronic asthma;
- •Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone [PTH], etc.);
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol;
- •Pregnancy or lactation for female subjects of child-bearing potential (i.e., < two years post-menopausal or not surgically sterile);
- •For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods;
- •Severe renal or hepatic impairment.
研究组 & 干预措施
ALZT-OP1a
ALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.
干预措施: Cromolyn (Drug)
Placebo
ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.
干预措施: Placebo (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: Baseline and Week 12
The primary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to Week 12 scored on MoCA.
次要结局
- Mini Mental State Examination (MMSE)(Baseline and Week 12)