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

NCT ID: NCT07338682

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Cognition Disorders in Old Age; Cognitive and Behavioral Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

L-Arginine

6 grams sachets of L-arginine once daily

Group Type: EXPERIMENTAL

L-Arginine

Intervention Type: DIETARY_SUPPLEMENT

6 grams L-arginine sachets taken orally once daily

Placebo

Matching placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching Placebo of L-arginine

Interventions

L-Arginine

6 grams L-arginine sachets taken orally once daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Matching Placebo of L-arginine

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German University in Cairo

OTHER

Sponsor Role: lead

Responsible Party

Rama Elmor

Teaching Assistant/Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neurology Department, Al-Azhar University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Rama Elmor

Role: primary

rama.mohamed@guc.edu.eg

+201013899711

Other Identifiers

L-Arg_on_MCI_in_Geriatrics

Identifier Type: -

Identifier Source: org_study_id