Tests tributyrin supplement against placebo in people with mild Alzheimer disease
Tests whether a daily tributyrin supplement affects memory decline in adults with mild Alzheimer disease.
Plain-language title generated from the registry record
Registry title: Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain
Key facts
- Where
- Almería, SpainSee the site
- Phase
- Phase 3
Where in Spain
- Universidad de AlmeríaAlmería, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidad de Almeria
- Trial code
- NCT06797817
- Record updated
- 18 December 2025
- Original description
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:Read full original descriptionShow less
Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain
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.
Inclusion: 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.
Exclusion: 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 other potential causes of dementia, such as a history of severe traumatic brain injury, brain tumours, epilepsy, or central nervous system infections; individuals with gastrointestinal disorders.