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
Qualifiers
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
Treatments tested in this trial
- Tributyrin
- Placebo
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prabesh Kanel
Lead sponsor
University of Michigan
Sponsor institution
Farmer Family Foundation
Collaborator
Source ClinicalTrials.gov