NCT07154511 · Prabesh Kanel
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
(BUTTER2)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Tributyrin
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
DRUG
Placebo
Participants will take 500mg TID placebo for 90 days +/- 7 days.
Primary outcome measures
Single composite global cognitive z-score
Time frame: Baseline and post-intervention (83-97 days after starting supplement)
A global cognitive z-score derived from a neuropsychological battery including the California Verbal Learning Test (short- and long-term memory), Delis-Kaplan Executive Function System (verbal fluency via letter fluency test, executive function via Stroop and Trail Making Test Part 4), and Benton Judgment of Line Orientation Test (visuospatial cognition). Individual test scores are normatively z-scored with age- and sex-adjustment using data from 55 cognitively normal controls (Montreal Cognitive Assessment score \> 25). All z-scores are aligned so that higher scores indicate better performance. Scores are averaged within domains and then across domains to compute the global cognitive z-score.
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score
Time frame: Baseline and post-intervention (83-97 days after starting supplement)
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.
Safety and tolerability of tributyrin
Time frame: During and after 83-97 day supplementation period
Safety and tolerability are assessed by monitoring the incidence, severity, and relationship of adverse events (AEs), serious adverse events (SAEs), and discontinuations due to AEs. AE information via biweekly phone-call monitoring, and during the post-intervention study visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
- Evidence of large vessel stroke or mass lesion on MRI.
- Regular use of typical anti-cholinergic drugs.
- Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.
- Significant metabolic or uncontrolled medical comorbidity.
- Pregnant or nursing.
- Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
- Any other condition or criterion that would preclude safe and meaningful participation in the study.
Where
- Ann Arbor, Michigan
Collaborators
Farmer Family Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations