Phase 2 Trial of Tributyrin for Parkinson's Disease and Cognitive Impairments
This study is testing if a dietary supplement called tributyrin can help improve memory, thinking, walking, and balance in adults with Parkinson's disease (PD) or Parkinson's disease dementia (PDD). Researchers want to see if tributyrin improves test scores for these abilities and what side effects people might experience. You could be eligible if you are 45 or older and have been diagnosed with PD with mild cognitive impairment or PDD. The study compares tributyrin to a placebo (an inactive substance) to understand its effects. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 45 participants. It compares tributyrin to a placebo.
- What's involved
- You would take either tributyrin or a placebo three times a day for about 90 days. You would also complete motor and cognitive tests at the clinic before and after this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability to tributyrin will be monitored during and after the 83-97 day supplementation period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
At a glance
Conditions
NCT07154511
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Domino's Farms
Ann Arbor, Michiganstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Prabesh Kanel, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan
Who to contact
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Inclusion
Exclusion
What this trial measures
- Single composite global cognitive z-scoreBaseline and post-intervention (83-97 days after starting supplement)
A global cognitive z-score derived from a neuropsychological battery including the California Verbal Learning Test (short- and long-term memory), Delis-Kaplan Executive Function System (verbal fluency via letter fluency test, executive function via Stroop and Trail Making Test Part 4), and Benton Judgment of Line Orientation Test (visuospatial cognition). Individual test scores are normatively z-scored with age- and sex-adjustment using data from 55 cognitively normal controls (Montreal Cognitive Assessment score \> 25). All z-scores are aligned so that higher scores indicate better performance. Scores are averaged within domains and then across domains to compute the global cognitive z-score.
- Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III ScoreBaseline and post-intervention (83-97 days after starting supplement)
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.
- Safety and tolerability of tributyrinDuring and after 83-97 day supplementation period
Safety and tolerability are assessed by monitoring the incidence, severity, and relationship of adverse events (AEs), serious adverse events (SAEs), and discontinuations due to AEs. AE information via biweekly phone-call monitoring, and during the post-intervention study visit.