RightFit
RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 90 days
  • Procedures mentioned: MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Complete brain imaging (MRI scans and PET scans) before and after the supplementation period."
  • "The overarching goal of this project is to perform a parallel group, double-blinded, randomized placebo-controlled phase 2 clinical trial of tributyrin, 500 mg tid po for 90 days, to validate and extend these preliminary observations in a longer duration clinical trial in people with PD with mild cognitive impairment (PD-MCI) or Parkinson disease dementia (PDD)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

MI