Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

The objective of this study is to understand the bioenergetic impairments that underlie Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will result in increased brain ATP levels in individuals with Parkinson's disease (PD). The specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day) simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral measurements of UDCA (and associated conjugates) and peripheral measures and/or central (brain) bioenergetic measurements.

Key facts

Study ID

NCT02967250

Run by

University of Minnesota

People needed

5

Starts

2020-04-01

Expected to finish

2022-02-28

Last updated by the study team

2022-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All participants must be 18 years or older.
• All enrollees must understand and cooperate with requirements of the study and be able to provide written informed consent
• Individuals with medically stable mild to moderate Parkinson's disease or healthy controls (as determined by enrolling investigator)
• All participants must not have taken UDCA for 4 weeks prior to the study.
• Absence of dementia in all subjects, as determined by pre-scanning cognitive assessment.

You may not qualify if…

• Inability to undergo MRI scanning without sedation and other MRI counterindications, such as metal in the body.
• Medically unstable conditions
• Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
• Unable to adhere to study protocol as determined by the PI

Where it is running

• Center for Magnetic Resonance Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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