RecruitingPhase 1Phase 2NCT07154511

Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments

Sponsor

Prabesh Kanel

Enrollment

45 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Parkinson Disease Dementia

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.

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing tributyrin — a dietary supplement derived from a short-chain fatty acid — in people with Parkinson's disease who also have mild cognitive impairment or Parkinson's disease dementia. Researchers believe tributyrin may support brain health through gut-brain pathways. **You may be eligible if...** - You are 45 or older - You have a confirmed diagnosis of Parkinson's disease with mild cognitive impairment or Parkinson's disease dementia - If you take cholinesterase inhibitors, benzodiazepines, memantine, or antipsychotics, you must have been on a stable dose for at least 4 weeks **You may NOT be eligible if...** - You have an atypical form of parkinsonism (not standard Parkinson's disease) - You have metal implants or other contraindications to MRI (e.g., pacemaker, cochlear implant, severe claustrophobia) - You have evidence of a major stroke or brain mass on MRI - You regularly use anticholinergic drugs - You have significant uncontrolled gastrointestinal disease or another major medical condition - You are pregnant or nursing - You have active suicidal thoughts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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