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

NCT07154511 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-12

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Parkinson Disease Dementia

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.

Sponsors & Collaborators

  • Farmer Family Foundation

    collaborator UNKNOWN

  • Prabesh Kanel

    lead OTHER

Principal Investigators

  • Prabesh Kanel, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154511 on ClinicalTrials.gov