Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Prabesh Kanel
Summary
The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance in adults with Parkinson disease Parkinson disease dementia. It will also learn about the safety of tributyrin supplementation. The main questions it aims to answer are: 1. Does tributyrin improve memory/thinking test scores and walking/balance ability? 2. What medical problems do participants have when taking tributyrin? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no drug) to see if tributyrin works to treat Parkinson disease symptoms. Participants will: 1. Take tributyrin 3 times a day for 80-100 days 2. Complete motor and cognitive testing at the clinic before and after the supplementation period 3. Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.
Description
Changes in cognition, progressing usually to dementia, are common features of Parkinson disease (PD). These debilitating impairments respond poorly to current anti-dementia treatments and call for novel strategies. Short chain fatty acids (SFCA), in particular butyric acid (BA), are naturally present in the colon as a bacterial product of dietary fiber fermentation. There is renewed interest in SCFAs because of their potential as alternative substrates in brain metabolism, their role in the gut-brain axis, and emerging evidence that interventions promoting SCFA benefit patients with neurodegen…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or Female, age 45 years and over. * Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992) AND evidence of mild cognitive impairment (Litvan et al., 2012) OR Diagnosis of PDD (Emre et al., 2007). * If taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, on a stable regimen as defined by no medication changes for these drugs in prior 4 weeks. Exclusion Criteria: * Evidence of atypical parkinsonism. * Contra-indications to MR imaging including but n…
Interventions
- DrugTributyrin
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
- DrugPlacebo
Participants will take 500mg TID placebo for 90 days +/- 7 days.
Location
- Domino's FarmsAnn Arbor, Michigan