Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients, A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MOCA Score
研究概览
简要总结
This study aims to evaluate the effect of L-arginine supplementation on cognitive function in geriatric patients. Eligible participants will receive either L-arginine (6 grams once daily) or placebo, and their cognitive performance will be assessed using validated cognitive assessment tools over the study period. The participants will receive the intervention for 4 weeks and followed up every 2 weeks. The primary outcome is improvement in cognitive function, while secondary outcomes include safety, tolerability, and quality of life measures. The findings may provide evidence for the potential role of L-arginine in supporting cognitive health in elderly populations.
详细描述
Cognitive decline is a common problem in the geriatric population and can significantly affect independence, quality of life, and overall health outcomes. Emerging evidence suggests that L-arginine, a semi-essential amino acid and precursor for nitric oxide synthesis, may play a role in improving cerebral blood flow and neuronal function. These mechanisms could potentially contribute to better cognitive performance in elderly individuals.
This study is designed to evaluate the effect of L-arginine supplementation on cognitive function in geriatric patients. Participants who meet eligibility criteria will be randomized to receive either L-arginine supplementation or placebo. Cognitive function will be assessed at baseline and at defined intervals during the study period using validated neurocognitive assessment tools. Additional measures will include safety monitoring, tolerability, and secondary assessments such as quality of life indices.
The primary objective is to determine whether L-arginine supplementation improves cognitive function. Secondary objectives include evaluating the anti-inflammatory, antioxidant effect and safety profile of L-arginine in older adults and assessing its potential impact on daily living and overall well-being. The results of this study may provide valuable insights into the role of L-arginine in supporting cognitive health in elderly populations and inform future clinical practice.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age >60 years
- •Montreal Cognitive Assessment (MoCA) test score from 10-25 (mild to moderate cognitive impairment)
排除标准
- •Presence of neurodegenerative diseases (e.g.: Alzheimer's disease, Parkinson's disease, Huntington's disease, Multiple Sclerosis)
- •Patients with history of L-arginine intolerance or allergy
- •Patients with asthma
- •Patients who recently had an acute myocardial infarction
- •Patients with history of stroke within 1 yaear
- •Patients who started or discontinued medications that may affect cognitive function (e.g., CNS psychotropics, antihistamines, or acetylcholinesterase inhibitors) during the study period.
- •Patients who initiated or stopped antihypertensive medications during the study period.
- •Patients who initiated or stopped antidiabetic medications during the study period.
- •Patients who initiated or stopped antihyperlipidemic medications during the study period.
- •Patients prescribed medications for depression, anxiety, or stress that may impact cognitive function
- •Patients on nitrates, phosphodiesterase-5 inhibitors, potassium sparing diuretics
- •Refusal to provide written informed consent
研究组 & 干预措施
L-Arginine
6 grams sachets of L-arginine once daily
干预措施: L-Arginine (Dietary Supplement)
Placebo
Matching placebo once daily
干预措施: Placebo (Other)
结局指标
主要结局
MOCA Score
时间窗: at baseline, after 2 weeks, and after 4 weeks
Montreal Cognitive Assessment (MoCA)
次要结局
- DASS-21(at baseline, after 2 weeks, and after 4 weeks)
- WHOQOL-BREF(at baseline, after 2 weeks, and after 4 weeks)
- ADMA(at baseline and after 4 weeks)
- MDA(at baseline and after 4 weeks)
- CRP(at baseline and after 4 weeks)
- Lipid Profile(at baseline and after 4 weeks)
- Kidney Function test(at baseline and after 4 weeks)
- Liver Function Tests(at baseline and after 4 weeks)
研究者
Rama Elmor
Teaching Assistant/Pharmacist
German University in Cairo