Tributyrin for Parkinson's Disease Dementia

(BUTTER2 Trial)

This trial tests whether a supplement called tributyrin can improve memory, thinking, walking, and balance in people with Parkinson's disease dementia. Researchers aim to determine if tributyrin makes a difference compared to a placebo, which resembles the supplement but contains no active ingredients. The trial will also monitor any side effects from taking tributyrin. People with Parkinson's disease who have mild memory issues or dementia might be suitable candidates if their medication routine has remained stable for the past month. As a Phase 1, Phase 2 trial, this research focuses on understanding how tributyrin works and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

The trial does not specify that you need to stop taking your current medications. However, if you are taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, you must be on a stable regimen without changes for at least 4 weeks before joining the trial.

Research has shown that tributyrin is generally safe for people. In earlier studies, patients who took 500 mg of tributyrin three times a day experienced few side effects, suggesting the treatment's safety. Additionally, compared to similar substances like butyrate, the body processes tributyrin more efficiently. Overall, current evidence supports tributyrin's safety for humans, with few negative effects reported.¹²³⁴⁵

Unlike the standard of care for Parkinson's Disease Dementia, which typically involves medications like cholinesterase inhibitors and levodopa to manage symptoms, Tributyrin acts on a different front. This investigational treatment is unique because it uses a short-chain fatty acid derivative that may have neuroprotective effects, potentially addressing the root causes of dementia associated with Parkinson’s. Researchers are excited about Tributyrin's potential to improve cognitive function by enhancing brain health, rather than just alleviating symptoms, which could represent a significant advancement in treatment.

Research has shown that tributyrin might improve brain function in people with Parkinson's disease. Tributyrin converts into a beneficial fatty acid in the body, potentially boosting brain energy use and aiding memory and thinking. Early studies suggest that tributyrin can overcome some challenges of natural butyrate, enhancing absorption by the body. In this trial, participants will receive either tributyrin supplementation or a placebo. Although researchers are still studying this treatment, these initial findings offer promise for improving symptoms related to Parkinson's disease dementia.¹²³⁴⁶