Tributyrin for Parkinson's (NCT07154511)
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
Goal: to see whether a tributyrin supplement can improve memory and thinking and also help walking and balance in people with Parkinson's who have mild cognitive problems or dementia, and to check the supplement's safety. Approach: participants take tributyrin three times a day for about 90 days and are compared to a placebo, with movement and thinking tests plus brain scans (magnetic resonance imaging and positron emission tomography) before and after; tributyrin is a form of butyric acid that is absorbed and broken down inside cells to release the active substance over time, and earlier work showed it reaches the brain, helped thinking in short trials, and reduced inflammation. Eligibility: adults 45 and older with Parkinson's plus mild cognitive impairment or Parkinson disease dementia, able to have the required brain scans, without major other medical or gut problems, and on stable doses of certain dementia or psychiatric medications if applicable.
Locations
- Domino's Farms, Ann Arbor, Michigan, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Tributyrin. Goal: to see whether a tributyrin supplement can improve memory and thinking and also help walking and balance in people with Parkinson's who have mild cognitive problems or dementia, and to check the supplement's safety. Approach: participants take tributyrin three times a day for about 90 days and are compared to a placebo, with movement and thinking tests plus brain scans (magnetic resonance imaging and positron emission tomography) before and after; tributyrin is a form of butyric acid that is absorbed and broken down inside cells to release the active substance over time, and earlier work showed it reaches the brain, helped thinking in short trials, and reduced inflammation. Eligibility: adults 45 and older with Parkinson's plus mild cognitive impairment or Parkinson disease dementia, able to have the required brain scans, without major other medical or gut problems, and on stable doses of certain dementia or psychiatric medications if applicable.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 6 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will complete motor and cognitive testing and MRI/PET brain imaging at the clinic both before and after the supplementation period, which lasts 80-100 days.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Thinking & memory tests (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.