Status:
RECRUITING
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Lead Sponsor:
Prabesh Kanel
Collaborating Sponsors:
Farmer Family Foundation
Conditions:
Parkinson Disease
Parkinson Disease Dementia
Eligibility:
All Genders
45+ years
Phase:
PHASE1
PHASE2
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. ...
Detailed Description
Changes in cognition, progressing usually to dementia, are common features of Parkinson disease (PD). These debilitating impairments respond poorly to current anti-dementia treatments and call for nov...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07154511
Start Date
November 7 2025
End Date
May 1 2027
Last Update
November 12 2025
Active Locations (1)
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1
Domino's Farms
Ann Arbor, Michigan, United States, 48105