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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Prabesh Kanel
Study ID
NCT07154511
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tributyrin — DRUG
    Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
  • Placebo — DRUG
    Participants will take 500mg TID placebo for 90 days +/- 7 days.

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tributyrin Supplementation
    Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
  • Placebo Comparator: Placebo
    Participants will take 500mg placebo for 90 days +/- 7 days.

Primary Outcome Measure

Single composite global cognitive z-score [ Time Frame: Baseline and post-intervention (83-97 days after starting supplement) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Domino's FarmsAnn ArborMichigan48105
Robert Vangel, BSc
[email protected]
734-936-1168
Prabesh Kanel, PhD (PRINCIPAL_INVESTIGATOR)
Nicolaas Bohnen, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Domino's Farms· Ann Arbor, MI

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