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

NCT07154511 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HUM00270219
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does tributyrin improve memory/thinking test scores and walking/balance ability?
2. 2.What medical problems do participants have when taking tributyrin?
3. 3.Take tributyrin 3 times a day for 80-100 days
4. 4.Complete motor and cognitive testing at the clinic before and after the supplementation period
5. 5.Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.

Conditions

Parkinson Disease; Parkinson Disease Dementia

Keywords

short chain fatty acid; butyrate; tributyrin; functional neuroimaging

Outcome Measures

Primary Outcomes (3)

• Single composite global cognitive z-score

  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.

  Baseline and post-intervention (83-97 days after starting supplement)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score

  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.

  Baseline and post-intervention (83-97 days after starting supplement)

• Safety and tolerability of tributyrin

  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.

  During and after 83-97 day supplementation period

Study Arms (2)

Tributyrin Supplementation

EXPERIMENTAL

Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.

Drug: Tributyrin

Placebo

PLACEBO COMPARATOR

Participants will take 500mg placebo for 90 days +/- 7 days.

Drug: Placebo

Interventions

Tributyrin DRUG

Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.

Tributyrin Supplementation

Placebo DRUG

Participants will take 500mg TID placebo for 90 days +/- 7 days.

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prabesh Kanel: lead
• Farmer Family Foundation: collaborator

Study Sites (1)

Domino's Farms

Ann Arbor, Michigan, 48105, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Prabesh Kanel, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Vangel, BSc

CONTACT

734-936-1168; rvangel@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor of Radiology

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)