Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.
研究概览
简要总结
This clinical trial is focused on determining whether biological signatures of target engagement by a Centella asiatica water extract product administered orally for 6 weeks can be measured in comparison to placebo. This study will also assess the safety and tolerability of the Centella asiatica water extract product.
详细描述
This Phase I study is a randomized, double-blind, placebo-controlled, clinical trial of 48 participants to evaluate safety, tolerability, and biological signatures of target engagement of brain neuronal viability, oxidative stress, and brain mitochondrial activity of a Centella asiatica water extract product (CAP) in older adults aged 60-85 years with mild cognitive impairment or mild Alzheimer's disease (AD). The intervention is taken orally daily for six weeks and pre and post assessments will be collected.
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)
盲法说明
Drug product and placebo will be prepared at Oregon's Wild Harvest using a formula that matches taste, smell, and appearance. The Research Pharmacy at Oregon Health and Science University will maintain information on product allocation (drug or placebo) to individual participants.
入排标准
- 年龄范围
- 60 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
Centella asiatica water extract product (CAP) 4g
A sachet of containing 4g dried hot water extract (CAW) of Centella asiatica combined with inactive ingredients (excipients) will be dissolved in water and orally consumed daily as a drink for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.
干预措施: Centella asiatica product (Drug)
Placebo
A sachet of inactive ingredients (excipients) identical in composition to those found in the active arm will be be dissolved in water and orally consumed daily for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.
时间窗: Baseline and 6 weeks
N-acetylaspartate (NAA)/creatine (Cr) metabolite ratio (NAA/Cr) in the brain determined through 1H-Magnetic Resonance Spectroscopic Imaging of a single brain slice as an indicator of neuronal viability and mitochondrial activity.
次要结局
- Change from baseline in urinary 8-hydroxy-2-deoxyguanosine (8 OHdG)/creatinine ratio after 6 weeks on intervention.(Baseline and 6 weeks)
- Change from baseline in plasma 8-hydroxy-2-deoxyguanosine (8-OhdG) after 6 weeks on intervention.(Baseline and 6 weeks)
- Adverse events (AE) arising during, and up to 4 weeks after, 6 weeks on intervention.(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 10 weeks)
- Oral temperature measured at study visits.(Baseline and 6 weeks)
- Pulse rate measured at study visits.(Baseline and 6 weeks)
- Change from baseline in seated blood pressure after 6 weeks on intervention.(Baseline and 6 weeks)
- Change from baseline in body mass index after 6 weeks on intervention.(Baseline and 6 weeks)
- Change from baseline in electrocardiography signals after 6 weeks on intervention.(Baseline and 6 weeks)
- Change from baseline liver function after 6 weeks on intervention.(Baseline and 6 weeks)
- Change from baseline in kidney function after 6 weeks on intervention.(Baseline and 6 weeks)
研究者
Amala Soumyanath
Professor
Oregon Health and Science University