RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07154511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female, age 45 years and over.
  2. * 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).
  3. * 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.
  1. * Evidence of atypical parkinsonism.
  2. * Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
  3. * Evidence of large vessel stroke or mass lesion on MRI.
  4. * Regular use of typical anti-cholinergic drugs.
  5. * Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.
  6. * Significant metabolic or uncontrolled medical comorbidity.
  7. * Pregnant or nursing.
  8. * Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
  9. * Any other condition or criterion that would preclude safe and meaningful participation in the study.

Contacts and Locations

Study Contact

Robert Vangel, BSc
CONTACT
734-936-1168
rvangel@med.umich.edu

Principal Investigator

Prabesh Kanel, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Domino's Farms
Ann Arbor, Michigan, 48105
United States

Collaborators and Investigators

Sponsor: Prabesh Kanel

  • Prabesh Kanel, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-09
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • short chain fatty acid
  • butyrate
  • tributyrin
  • functional neuroimaging

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Parkinson Disease Dementia