[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604822":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tributyrin Supplementation","EXPERIMENTAL","Participants will take 500mg TID tributyrin supplement for 90 days +\u002F- 7 days.",[13],"Drug: Tributyrin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will take 500mg placebo for 90 days +\u002F- 7 days.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tributyrin","Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +\u002F- 7 days.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants will take 500mg TID placebo for 90 days +\u002F- 7 days.",[15],[31],{"name":32,"affiliation":5,"role":33},"Prabesh Kanel, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Robert Vangel, BSc","CONTACT","734-936-1168","rvangel@med.umich.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Domino's Farms","RECRUITING","Ann Arbor","Michigan","48105","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-83.74088,42.27756,{"lat":53,"lon":52},[56,57,58],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Nicolaas Bohnen, MD, PhD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Prabesh Kanel","Research Assistant Professor of Radiology",[66],{"name":67,"class":68},"Farmer Family Foundation","UNKNOWN","100604822","phase-1-phase-2-trial-of-tributyrin-in-people-with-parkinsons-disease-and-cognitive-impairments-100604822",false,"NCT07154511","Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments","BUTTER2","Inclusion Criteria:\n\n* Male or Female, age 45 years and over.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* Evidence of atypical parkinsonism.\n* Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.\n* Evidence of large vessel stroke or mass lesion on MRI.\n* Regular use of typical anti-cholinergic drugs.\n* Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.\n* Significant metabolic or uncontrolled medical comorbidity.\n* Pregnant or nursing.\n* Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.\n* Any other condition or criterion that would preclude safe and meaningful participation in the study.","ALL","45 Years",{"count":79,"type":80},45,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","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:\n\n1. Does tributyrin improve memory\u002Fthinking test scores and walking\u002Fbalance ability?\n2. What medical problems do participants have when taking tributyrin?\n\nResearchers will compare tributyrin to a placebo (a look-alike substance that contains no drug) to see if tributyrin works to treat Parkinson disease symptoms.\n\nParticipants will:\n\n1. Take tributyrin 3 times a day for 80-100 days\n2. Complete motor and cognitive testing at the clinic before and after the supplementation period\n3. Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.",[87,88],"Parkinson Disease","Parkinson Disease Dementia",[90,91,92,93],"short chain fatty acid","butyrate","tributyrin","functional neuroimaging","2025-11-10",{"date":96,"type":97},"2025-11-12","ACTUAL",{"date":99,"type":97},"2025-11-07",{"date":101,"type":80},"2027-05",{"name":63,"class":6},1]