Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorPrabesh Kanel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tributyrin
DrugPost-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
Placebo
DrugParticipants will take 500mg TID placebo for 90 days +/- 7 days.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Tributyrin SupplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Single composite global cognitive z-score
A global cognitive z-score derived from a neuropsychological battery including the California Verbal Learning Test (short- and long-term memory), Delis-Kaplan Executive Function System (verbal fluency via letter fluency test, executive function via Stroop and Trail Making Test Part 4), and Benton Judgment of Line Orientation Test (visuospatial cognition). Individual test scores are normatively z-scored with age- and sex-adjustment using data from 55 cognitively normal controls (Montreal Cognitive Assessment score \> 25). All z-scores are aligned so that higher scores indicate better performance. Scores are averaged within domains and then across domains to compute the global cognitive z-score.
Time frame
Baseline and post-intervention (83-97 days after starting supplement)2
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.
Time frame
Baseline and post-intervention (83-97 days after starting supplement)3
Safety and tolerability of tributyrin
Safety and tolerability are assessed by monitoring the incidence, severity, and relationship of adverse events (AEs), serious adverse events (SAEs), and discontinuations due to AEs. AE information via biweekly phone-call monitoring, and during the post-intervention study visit.
Time frame
During and after 83-97 day supplementation periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prabesh Kanel
Lead sponsor
University of Michigan
Sponsor institution
Farmer Family Foundation
Collaborator
Source ClinicalTrials.gov