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NCT Number: NCT07338682

Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients

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.

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Key information

Conditions

Cognition Disorders in Old Age Cognition Disorders Cognitive Dysfunction Cognitive and Behavioral Impairment Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurology Department, Al-Azhar University Hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Rama Elmor

CONTACT

[email protected]

+201013899711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Arginine

Dietary Supplement

6 grams L-arginine sachets taken orally once daily

Placebo

Other

Matching Placebo of L-arginine

Primary outcomes

  1. Montreal Cognitive Assessment (MOCA)

    Time frame: at baseline, after 2 weeks, and after 4 weeks

    MOCA is a is a brief cognitive screening tool used to detect mild cognitive impairment (MCI) and early dementia. It assesses multiple cognitive domains including memory, attention, executive function, language, visuospatial skills, abstraction, calculation, and orientation. The score ranges from 0- 30. The higher the score the better the cognition. The normal range is from 26-30.

Secondary outcomes

  1. Depression, Anxiety, Stress Scales-21 (DASS-21)

    Time frame: at baseline, after 2 weeks, and after 4 weeks

    DASS-21 is a short self-report questionnaire used to assess depression, anxiety, and stress over the past week. It consists of 21 items, with 7 items for each subscale, rated on a 4-point Likert scale. Each subscale has a raw score range of 0-21and the higher the score the worse the outcome of symptoms of depression, anxiety, or stress.

  2. The World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: at baseline, after 2 weeks, and after 4 weeks

    WHOQOL-BREF is a brief, self-administered questionnaire that assesses an individual's perceived quality of life. It consists of 26 items covering four domains: physical health, psychological health, social relationships, and environment. Score can range from 0-100 for each domain with higher scores meaning a better quality of life.

  3. ADMA

    Time frame: at baseline and after 4 weeks

    Asymmetric dimethylarginine

  4. MDA

    Time frame: at baseline and after 4 weeks

    Malondialdehyde

  5. CRP

    Time frame: at baseline and after 4 weeks

    C-reactive protein

  6. Lipid Profile

    Time frame: at baseline and after 4 weeks

  7. Kidney Function test

    Time frame: at baseline and after 4 weeks

    Serum Creatinine

  8. Liver Function Tests

    Time frame: at baseline and after 4 weeks

    ALT and AST

Sponsors and collaborators

Lead sponsor

German University in Cairo

Other

Registry information

Official study title

Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients, A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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