Actively Recruiting
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Led by Prabesh Kanel · Updated on 2025-11-12
45
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
P
Prabesh Kanel
Lead Sponsor
F
Farmer Family Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, age 45 years and over.
- Diagnosis of Parkinson disease based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria and evidence of mild cognitive impairment or diagnosis of Parkinson disease dementia.
- If taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, must be on a stable regimen with no medication changes in the prior 4 weeks.
You will not qualify if you...
- Evidence of atypical parkinsonism.
- Contraindications to MRI such as pacemakers, aneurysm clips, intraocular metal, cochlear implants, or severe claustrophobia.
- Evidence of large vessel stroke or mass lesion on MRI.
- Regular use of typical anti-cholinergic drugs.
- Recent significant uncontrolled gastrointestinal disease such as GERD or colorectal cancer.
- Significant metabolic or uncontrolled medical comorbidities.
- Pregnant or nursing.
- Suicidal ideation as shown by specific scores on the Beck Depression Inventory.
- Any other condition that would prevent safe and meaningful participation in the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Domino's Farms
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
R
Robert Vangel, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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