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Идёт набор NCT07338682

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

Фаза II С лечением Cognition Disorders in Old Age Cognitive and Behavioral Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: L-Arginine, Placebo.
Кому может быть актуально
Состояния в реестре: Cognition Disorders in Old Age, Cognitive and Behavioral Impairment. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients, A Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка L-Arginine
    6 grams L-arginine sachets taken orally once daily
  • Другое Placebo
    Matching Placebo of L-arginine

Первичные конечные точки

  • Montreal Cognitive Assessment (MOCA) [Срок оценки: at baseline, after 2 weeks, and after 4 weeks]
Вторичные конечные точки (8)
  • Depression, Anxiety, Stress Scales-21 (DASS-21) [Срок оценки: at baseline, after 2 weeks, and after 4 weeks]
  • The World Health Organization Quality of Life (WHOQOL-BREF) [Срок оценки: at baseline, after 2 weeks, and after 4 weeks]
  • ADMA [Срок оценки: at baseline and after 4 weeks]
  • MDA [Срок оценки: at baseline and after 4 weeks]
  • CRP [Срок оценки: at baseline and after 4 weeks]
  • Lipid Profile [Срок оценки: at baseline and after 4 weeks]
  • Kidney Function test [Срок оценки: at baseline and after 4 weeks]
  • Liver Function Tests [Срок оценки: at baseline and after 4 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Neurology Department, Al-Azhar University Hospitals — Cairo

Идентификаторы

NCT: NCT07338682 · L-Arg_on_MCI_in_Geriatrics

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗