NCT07154511 Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
| NCT ID | NCT07154511 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Prabesh Kanel |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2025-11-07 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 DLB (McKeith et al., 2017) or 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. * History of large vessel stroke or brain tumor * 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.
Contact & Investigator
Prabesh Kanel, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07154511 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07154511 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07154511 currently recruiting?
Yes, NCT07154511 is actively recruiting participants. Contact the research team at queg@med.umich.edu for enrollment information.
Where is the NCT07154511 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07154511 clinical trial?
NCT07154511 is sponsored by Prabesh Kanel. The principal investigator is Prabesh Kanel, PhD at University of Michigan. The trial plans to enroll 45 participants.
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