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Идёт набор NCT07011680

Phospholipid-rich Dairy Extract for Cognitive Function

Без фазы С лечением Cognitive Function Cognitive Decline

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: Phospholipid-rich dairy milk extract, Placebo.
Кому может быть актуально
Состояния в реестре: Cognitive Function, Cognitive Decline. Базовые параметры: 55 лет — 85 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A 12-week Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Dietary Phospholipid-rich Dairy Milk Extract on Cognitive Function Improvement in Adults With Mild Cognitive Impairment.

Обзор

This clinical trial aims to determine whether dietary phospholipid-rich dairy milk extract improves cognitive function in adults with mild cognitive impairment and to assess its safety. The main questions are: * Does dietary phospholipid-rich dairy milk extract improve cognitive function in participants? * What side effects occur when participants take phospholipid-rich dairy milk extract?

Подробное описание

Researchers will compare dietary phospholipid-rich dairy milk extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.

Participants will:

* Take dietary phospholipid-rich dairy milk extract or a placebo daily for 12 weeks. * Visit the clinic at 1, 2, 6, and 12 weeks for checkups and tests

Вмешательства

  • Пищевая добавка Phospholipid-rich dairy milk extract
    Dietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks
  • Пищевая добавка Placebo
    Placebo (Grape seed oil) 500 mg/day for 12 weeks

Первичные конечные точки

  • Change from baseline to 12 weeks in total Computerized NeuroCognitive Function Test score comprising verbal learning test, digit span test, and auditory continuous performance test [Срок оценки: 12 weeks]
Вторичные конечные точки (7)
  • Change from baseline to 12 weeks in verbal learning test score [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in digit span test score [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in auditory continuous performance test score [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration [Срок оценки: 12 weeks]
  • Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Age: Adults aged 55-85 years (inclusive), both male and female
  • Global Deterioration Scale (GDS) score of 2-3:

GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment

  • Absence of dementia according to established diagnostic criteria
  • Ability to read Korean

Критерии исключения

  • Severe medical conditions within the past 6 months: History of severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage), cardiac disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignancy (Note: Participants with a history of cerebrovascular or cardiac disease who are clinically stable may be included at the investigator's discretion)
  • Cognitive impairment-associated diseases: Dementia, Parkinson's disease, cerebral infarction, or other conditions associated with cognitive decline Uncontrolled hypertension: Blood pressure ≥160/100 mmHg (measured after 10 minutes of rest)
  • Poor glycemic control: Fasting blood glucose ≥160 mg/dL in diabetic patients
  • Uncontrolled thyroid dysfunction: Currently receiving treatment for uncontrolled hypothyroidism or hyperthyroidism
  • Renal impairment: Serum creatinine ≥2 times the upper limit of normal for the institution
  • Hepatic impairment: AST or ALT ≥2 times the upper limit of normal for the institution
  • Severe gastrointestinal symptoms: Complaints of severe heartburn, dyspepsia, or other gastrointestinal distress
  • Medications affecting cognitive function within the past month: Use of drugs (antipsychotics, anti-degenerative agents, cognitive enhancers, tricyclic antidepressants, hormone replacement therapy) or health functional foods that may influence cognitive function due to dementia or other cognitive abnormalities
  • Other clinical trial participation: Participation in other drug clinical trials within the past month or planned participation during the study period
  • Alcohol abuse
  • Food allergies: Known allergic reactions to study product components
  • Investigator discretion: Any other condition deemed inappropriate for study participation by the investigator

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

South Korea · 1 центр
  • Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT07011680 · 12-2024-013

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗