Tributyrin for memory, thinking, and walking problems in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 1/2 interventional study compares oral tributyrin to a matching placebo in adults with Parkinson's disease who have mild cognitive impairment or Parkinson disease dementia. Participants take tributyrin or placebo three times daily for roughly 80–100 days and undergo motor and cognitive testing before and after the supplementation period. Brain imaging with MRI and PET is performed at baseline and after treatment to look for changes in brain metabolism and structure, and safety monitoring is conducted throughout. The study excludes people with atypical parkinsonism, major uncontrolled medical or gastrointestinal conditions, or contraindications to MRI.

Why it matters

Who can join: the full rules

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 it's running

• Domino's Farms
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Prabesh Kanel, PhD — University of Michigan
• Study coordinator: Robert Vangel, BSc
• Email: rvangel@med.umich.edu
• Phone: 734-936-1168

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.