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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.