NCT06761066Enrolling By Invitation不适用
36-week, Single-center, Randomized, Double-blind, Parallel-design, Placebo-controlled Trial to Determine the Safety and Efficacy of NVP-NK4146 in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- amyloid PET scan
研究概览
简要总结
The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo
详细描述
36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 60 or older
- •Subject who meet the National Institute of Aging and Alzheimer's Associations (NIA-AA) core clinical criteria for MCI and have positive readings from amyloid PET
- •Subject who can read and understand the Informed Consent Form and legends and who voluntarily decided to participate in current clinical trial and have signed the Informed Consent Form
排除标准
- •Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10
- •Subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion)
- •Subject who are illiterate and/or without any education
- •Any other factors deemed by the investigator to be likely to ineligible for the study
研究组 & 干预措施
Active Group
Experimental
NVP-NK4146
干预措施: NVP-NK4146 (Dietary Supplement)
Placebo Group
Placebo Comparator
NVP-NK4146 Placebo
干预措施: NVP-NK4146 Placebo (Dietary Supplement)
结局指标
主要结局
amyloid PET scan
时间窗: baseline and 36 weeks
Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks
次要结局
- GDS (Global Deterioration Scale)(baseline and 36 weeks)
- K-MMSE (the Korean Mini-Mental State Examination)(baseline and 36 weeks)
- ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13(baseline and 36 weeks)
- CDR-SB(Clinical Dementia Rating-Sum of Boxes)(baseline and 36 weeks)
研究者
研究点 (1)
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