Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorGerman University in Cairo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >60 years
Montreal Cognitive Assessment (MoCA) test score from 10-25 (mild to moderate cognitive impairment)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
L-Arginine
Dietary supplement6 grams L-arginine sachets taken orally once daily
Placebo
Other interventionMatching Placebo of L-arginine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: L-ArginineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
at baseline, after 2 weeks, and after 4 weeksSecondary outcomes
1
Depression, Anxiety, Stress Scales-21 (DASS-21)
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.
Time frame
at baseline, after 2 weeks, and after 4 weeks2
The World Health Organization Quality of Life (WHOQOL-BREF)
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.
Time frame
at baseline, after 2 weeks, and after 4 weeks3
ADMA
Asymmetric dimethylarginine
Time frame
at baseline and after 4 weeks4
MDA
Malondialdehyde
Time frame
at baseline and after 4 weeksSponsors and contacts
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Source ClinicalTrials.gov