RECRUITING

Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments

Description

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

Parkinson DiseaseParkinson Disease Dementia
Talk to us

Related Conditions:

Parkinson DiseaseParkinson Disease Dementia

Study Overview

On this page

Study Details

Study overview

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.

Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments

Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Domino's Farms, Ann Arbor, Michigan, United States, 48105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Prabesh Kanel,

Prabesh Kanel, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2027-05