Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-Arginine, Placebo.
- Who it may be relevant to
- Registry conditions: Cognition Disorders in Old Age, Cognitive and Behavioral Impairment. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients, A Randomized Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement L-Arginine
6 grams L-arginine sachets taken orally once daily - Other Placebo
Matching Placebo of L-arginine
Primary outcome measures
- Montreal Cognitive Assessment (MOCA) [Time frame: at baseline, after 2 weeks, and after 4 weeks]
Secondary outcome measures (8)
- Depression, Anxiety, Stress Scales-21 (DASS-21) [Time frame: at baseline, after 2 weeks, and after 4 weeks]
- The World Health Organization Quality of Life (WHOQOL-BREF) [Time frame: at baseline, after 2 weeks, and after 4 weeks]
- ADMA [Time frame: at baseline and after 4 weeks]
- MDA [Time frame: at baseline and after 4 weeks]
- CRP [Time frame: at baseline and after 4 weeks]
- Lipid Profile [Time frame: at baseline and after 4 weeks]
- Kidney Function test [Time frame: at baseline and after 4 weeks]
- Liver Function Tests [Time frame: at baseline and after 4 weeks]
Eligibility criteria
Inclusion criteria
- Age >60 years
- Montreal Cognitive Assessment (MoCA) test score from 10-25 (mild to moderate cognitive impairment)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Neurology Department, Al-Azhar University Hospitals — Cairo
Identifiers
NCT: NCT07338682 · L-Arg_on_MCI_in_Geriatrics