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

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

This trial will test whether taking tributyrin three times a day for about 80–100 days helps memory, thinking, walking, and balance in adults with Parkinson's disease or Parkinson disease dementia, and will monitor safety.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: University of Michigan (other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT07154511 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 45 or older with Parkinson's disease and mild cognitive impairment or with Parkinson disease dementia, who are medically stable and able to undergo MRI and PET scans, are the intended participants.

Not a fit: People with atypical parkinsonism, significant uncontrolled medical or GI disease, MRI contraindications, regular anticholinergic use, or those who are pregnant or nursing are unlikely to be eligible or to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, tributyrin could improve cognition and gait/balance in people with Parkinson's-related cognitive impairment and offer a new oral approach targeting brain metabolism.

How similar studies have performed: Preclinical data and some small studies suggest short-chain fatty acids or butyrate may affect brain metabolism and neurodegeneration, but oral tributyrin has limited prior testing in Parkinson's and remains an early-stage approach.

Eligibility criteria

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 this trial is running

Ann Arbor, Michigan

• Domino's Farms — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Prabesh Kanel, PhD — University of Michigan
• Study coordinator: Robert Vangel, BSc

Conditions: Parkinson Disease, Parkinson Disease Dementia, short chain fatty acid, butyrate, tributyrin, functional neuroimaging