Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
45 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Prabesh Kanel · Other
Who this trial is looking for
This trial is looking for adults with Parkinson's disease who have mild memory problems. Participants will take a supplement called tributyrin three times a day for about 3 months and complete tests about their thinking and movement.
Are You a Good Fit for This Trial?
You may be able to join if
I am 45 years or older.
I have been diagnosed with Parkinson's disease or Parkinson's disease dementia.
I show signs of mild cognitive impairment.
I have not changed my cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications in the past 4 weeks.
You may not be able to join if
I have atypical parkinsonism.
I cannot have MR imaging due to devices like pacemakers or severe claustrophobia.
I have had a large vessel stroke or mass lesion on my MRI.
I regularly use typical anti-cholinergic drugs.
I have had significant uncontrolled gastrointestinal disease recently.
I have significant metabolic or uncontrolled medical issues.
I am pregnant or nursing.
I have suicidal thoughts.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Wha…
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.
Trial Locations
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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 PDD (Emre et al., 2007…
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 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.
* 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.
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