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

G

German University in Cairo

Status and phase

Enrolling
Phase 2

Conditions

Cognitive and Behavioral Impairment
Cognition Disorders in Old Age

Treatments

Dietary Supplement: L-Arginine
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07338682
L-Arg_on_MCI_in_Geriatrics

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

L-Arginine
Experimental group
Description:
6 grams sachets of L-arginine once daily
Treatment:
Dietary Supplement: L-Arginine
Placebo
Placebo Comparator group
Description:
Matching placebo once daily
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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