A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of NA-831 in Alzheimer Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24
研究概览
简要总结
This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive impairment due to Alzheimer's Disease
详细描述
Mild cognitive impairment ("MCI") is defined as the "symptomatic pre-dementia stage" on the continuum of cognitive decline. Currently, no medications have proven effective for MCI. Preclinical experiments indicate that NA-831 is an endogenous small molecule that exhibits neuroprotection, neurogenesis, and cognitive protective properties across a range of disease models. NA-831 has been shown to be safe and well tolerated in healthy volunteers. This study seeks to evaluate the efficacy and safety of NA-83 in 126 subjects with mild cognitive impairment due to 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
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low-dose N-831(Traneurocin)- 10 mg QD
Oral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks
干预措施: N-831(Traneurocin) 10 mg QD (Drug)
Medium-dose NA-831(Traneurocin)- 20 mg QD
Oral administration of 20 mg of NA-831(Traneurocin) per day for 24 weeks
干预措施: NA-831 (Traneurocin) 20 mg QD (Drug)
High-dose NA-831(Traneurocin)- 40 mg QD
Oral administration of 40 mg of NA-831(Traneurocin) per day for 24 weeks
干预措施: NA-831 (Traneurocin) 40 mg QD (Drug)
Placebo
Oral administration of placebo per day for 24 weeks
干预措施: Placebo oral capsule QD (Drug)
结局指标
主要结局
Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24
时间窗: Week 24
To study to the change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at Week 2 and Week 24. The CDR-SB is obtained through interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18 with the higher values represent worse outcome.
次要结局
- 1. Mean difference between the last (Week 24) and first (Week 2) postdose using Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) assessment(Week 24)
- Assess the change from baseline in ADCS-ADL MCI at Week 24(Week 24)