NCT07154511RecruitingPhase 1/2
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Source: ClinicalTrials.gov · Last updated 12 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 7 Nov 2025
- Primary completion date
- May 2027
- Lead sponsor
- Prabesh Kanel
- Diseases
- Parkinson disease
- NCT number
- NCT07154511
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 45
- From 7 Nov 2025 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
- Regular use of typical anti-cholinergic drugs.
Other illness
- Evidence of large vessel stroke or mass lesion on MRI.
- Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.
- Any other condition or criterion that would preclude safe and meaningful participation in the study.
Other
- Evidence of atypical parkinsonism.
- 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.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Domino's Farms Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.