Clinical trial NCT06797817: Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyric Acid Effects Via the Gut-Brain
Official title: Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyric Acid Effects Via the Gut-Brain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Alzheimer Disease (AD)
Keywords: butyrate
cognitive decline
cytokines
oxidative stress
gut microbiome
tributyrin
alzheimer disease
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial (1:1), parallel, and double-blind will be conducted. This study will adhere to the guidelines outlined by the CONsolidated Standards of Reporting Trials (CONSORT)
Primary purpose: TREATMENT

Brief summary: 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 improve cognitive function in patients with mild AD? Does tributyrin reduce inflammation and oxidative stress? 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 BDNF and GFAP), and gut health.

The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
Secondary outcomes:
measure: Accuracy in N-back Task (Working Memory)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Reaction Time in N-back Task (Working Memory)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Verbal memory by Rey Test
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Visual memory by Rey Test
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Reaction time in Stroop Test (Attention)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Accuracy in Stroop Test (Attention)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Completion Time in KEFS test (Cognitive flexibility)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Accuracy in KEFS test (Cognitive flexibility)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Accuracy in Go/No-Go test (Inhibition)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Reaction time in Go/No-Go test (Inhibition)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Executive functions and impulsivity
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Financial Management in IADL assessment (Independence)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Meal preparation in IADL assesment (independence)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Taking medication in IADL assesment (independence)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Using transportation in IADL assesment (independence)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Systemic inflammation
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Serum SOD levels
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Serum MDA levels
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Concentration of Tight Junction Proteins
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Serum Levels of BDNF
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Serum Levels of GFAP
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Composition of Intestinal Microbiota (16S rRNA Gene Sequencing)
timeFrame: Change from Baseline to 12 weeks and 24 weeks
measure: Levels of SCFAs (Acetic Acid, Propionic Acid, and Butyric Acid) in faeces
timeFrame: Change from Baseline to 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Universidad de Almería
Study officials:
References: