Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain

Обзор

The goal of this clinical trial is to learn if tributyrin can help prevent or mitigate cognitive decline in individuals with mild Alzheimer's disease (AD). The trial will also examine the safety and effects of tributyrin on inflammation and gut microbiota. The main questions it aims to answer are: Does tributyrin reduce inflammation and neurodegeneration markers? How does tributyrin affect gut microbiota and intestinal permeability? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no active ingredient) to evaluate its effectiveness. Participants will: Take tributyrin or a placebo every day for 12 weeks. Undergo assessments of cognitive function, blood markers (such as NfL and pTau217), and gut health. The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.

Вмешательства

• Пищевая добавка tributyrin
  Participants will receive 1 capsule per day for 12 weeks. Each capsule contains 450 mg of tributyrins. The capsules will have a gelatin coating. In the market, formulations are available with dosages ranging from 200 to 500 mg.
• Другое Placebo
  The placebo will consist of potato starch encapsulated under identical conditions to those used for the tributyrin capsules, ensuring adequate blinding of the study.

Первичные конечные точки

• Montreal Cognitive Assessment (MoCA) [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]

Вторичные конечные точки (12)

• Levels of SCFAs (Acetate, Propionate and Butyrate) in faeces [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Intestinal permeability [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Systemic inflammation [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Serum levels of NfL [Срок оценки: Change from baseline to 12 weeks and 24 weeks]
• Serum levels of pTau217 [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Serum levels of Amyloid42/40 ratio [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Composition of Intestinal Microbiota (16S rRNA Gene Sequencing) [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Accuracy in N-back Task (Working Memory) [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Reaction Time in N-back Task (Working Memory) [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Verbal memory by Rey Test [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Visual memory by Rey Test [Срок оценки: Change from Baseline to 12 weeks and 24 weeks]
• Sustained attention by CPT [Срок оценки: Change from baseline to 12 weeks and 24 weeks]

Критерии участия

Критерии включения

• individuals diagnosed with mild AD within the past year (ICD-10: F00.1).
• voluntary consent to participate in the study in accordance with the Declaration of Helsinki.
• not currently enrolled in any other clinical trial that could confound the results.

Критерии исключения

• individuals with other potential causes of dementia, such as a history of severe traumatic brain injury, brain tumours, epilepsy, or central nervous system infections.
• individuals involved in an intervention that interferes with the trial (immunosuppressive drugs, steroids, antibiotics, or received chemotherapy in the month prior to the start of the intervention).
• individuals with gastrointestinal disorders.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad de Almería — Almería

Идентификаторы

NCT: NCT06797817 · 066160941-160941-4-824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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