drugset / Trial / NCT02967250

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

NCT02967250

Phase 1 Completed 5 enrolled University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-04-01
Primary completion
2022-02-28
Completion
2022-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 50 mg/kg Oral

Indications