Improve cognitive function with tributyrin
- Trial ID
- NCT07154511
- Official Title
- Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
- Goal
- Improve cognitive function with tributyrin
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Prabesh Kanel
- Study Type
- INTERVENTIONAL
- Enrollment
- 45 participants
- Conditions
- Parkinson Disease, Parkinson Disease Dementia
- Interventions
- Tributyrin, Placebo
Plain-Language Summary
The trial is testing whether tributyrin can help with the thinking and memory problems that occur in people with Parkinson's, including mild cognitive impairment and Parkinson's disease dementia. Tributyrin is an oral prodrug that raises levels of butyrate, a short-chain fatty acid that can reduce neuroinflammation, support neuronal health, and change gene activity through histone deacetylase inhibition; participants will receive tributyrin or placebo while staying on their usual Parkinson's medicines, since it is not a dopaminergic replacement and the study expects stable PD medication regimens. Adults 45 and older with Parkinson's plus mild cognitive impairment or PDD can join, provided they can have MRI, do not have atypical parkinsonism or major uncontrolled medical or GI issues, are not regularly using anticholinergic drugs, and are not pregnant or suicidal.
Locations
- Domino's Farms, Ann Arbor, Michigan, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Tributyrin. The trial is testing whether tributyrin can help with the thinking and memory problems that occur in people with Parkinson's, including mild cognitive impairment and Parkinson's disease dementia. Tributyrin is an oral prodrug that raises levels of butyrate, a short-chain fatty acid that can reduce neuroinflammation, support neuronal health, and change gene activity through histone deacetylase inhibition; participants will receive tributyrin or placebo while staying on their usual Parkinson's medicines, since it is not a dopaminergic replacement and the study expects stable PD medication regimens. Adults 45 and older with Parkinson's plus mild cognitive impairment or PDD can join, provided they can have MRI, do not have atypical parkinsonism or major uncontrolled medical or GI issues, are not regularly using anticholinergic drugs, and are not pregnant or suicidal.
- Who can participate?
- Participants must be at least 45 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 6 months.