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

NCT07338682 | Recruiting Phase 2 DMC

• 1 other identifier: L-Arg_on_MCI_in_Geriatrics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition Disorders in Old Age; Cognitive and Behavioral Impairment

Keywords

L-arginine; Cognitive impairment; Geriatrics; Elderly; Cognitive Function; Nitric Oxide

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MOCA)

  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.

  at baseline, after 2 weeks, and after 4 weeks

Secondary Outcomes (8)

• Depression, Anxiety, Stress Scales-21 (DASS-21)

  at baseline, after 2 weeks, and after 4 weeks

• The World Health Organization Quality of Life (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

Study Arms (2)

L-Arginine

EXPERIMENTAL

6 grams sachets of L-arginine once daily

Dietary Supplement: L-Arginine

Placebo

PLACEBO COMPARATOR

Matching placebo once daily

Other: Placebo

Interventions

L-Arginine DIETARY_SUPPLEMENT

6 grams L-arginine sachets taken orally once daily

L-Arginine

Placebo OTHER

Matching Placebo of L-arginine

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>60 years
• Montreal Cognitive Assessment (MoCA) test score from 10-25 (mild to moderate cognitive impairment)

You may not qualify if:

• 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

Sponsors & Collaborators

• German University in Cairo: lead

Study Sites (1)

Neurology Department, Al-Azhar University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Arginine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant/Pharmacist

Model Details: Randomized, double blinded, controlled clinical trial

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: August 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)