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Cognition Disorders in Old AgePhase 2NCT07338682

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

A Phase 2 study testing L-Arginine in people with Cognition Disorders in Old Age and Cognitive and Behavioral Impairment, run by German University in Cairo at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
L-Arginine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
27 Aug 2025to 30 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting

  • Neurology Department, Al-Azhar University Hospitals

    Cairo

    Rama Elmor, +201013899711, rama.mohamed@guc.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients, A Randomized Clinical 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.

Read the 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.

Being tested
L-Arginine, Placebo
Keywords
L-arginine, Cognitive impairment, Geriatrics, Elderly, Cognitive Function, Nitric Oxide
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-ArginineDietary supplement

    6 grams L-arginine sachets taken orally once daily

  • PlaceboOther

    Matching Placebo of L-arginine

Study groups in NCT07338682
Study groupRoleWhat they receive
L-ArginineExperimental6 grams sachets of L-arginine once daily
Receives: Dietary Supplement: L-Arginine
PlaceboPlacebo comparatorMatching placebo once daily
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at baseline, after 2 weeks, and after 4 weeks

Secondary outcomes (8)

  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.

    Measured: at baseline, after 2 weeks, and after 4 weeks

  2. 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.

    Measured: at baseline, after 2 weeks, and after 4 weeks

  3. ADMA

    Asymmetric dimethylarginine

    Measured: at baseline and after 4 weeks

  4. MDA

    Malondialdehyde

    Measured: at baseline and after 4 weeks

  5. CRP

    C-reactive protein

    Measured: at baseline and after 4 weeks

  6. Lipid Profile

    Measured: at baseline and after 4 weeks

  7. Kidney Function test

    Serum Creatinine

    Measured: at baseline and after 4 weeks

  8. Liver Function Tests

    ALT and AST

    Measured: at baseline and after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start27 Aug 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double blinded, controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07338682
Sponsor's protocol ID
L-Arg_on_MCI_in_Geriatrics
Status last verified
Jan 2026
First submitted
4 Jan 2026
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-Arginine in people with Cognition Disorders in Old Age and Cognitive and Behavioral Impairment, run by German University in Cairo at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MOCA) (time frame: at baseline, after 2 weeks, and after 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07338682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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