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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02967250
Date of registration: 13/09/2016
Prospective Registration: Yes
Primary sponsor: University of Minnesota
Public title: Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment
Scientific title: 7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment
Date of first enrolment: April 1, 2020
Target sample size: 20
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT02967250
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Lisa Coles
Address: 
Telephone: 410-926-4788
Email: durh0016@umn.edu
Affiliation: 
Name:     Lisa Coles, PhD
Address: 
Telephone: 4109264788
Email: durh0016@umn.edu
Affiliation: 
Name:     Lisa Coles, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Minnesota
Name:     Paul Tuite, MD
Address: 
Telephone:
Email:
Affiliation:  University of Minnesota
Key inclusion & exclusion criteria

Inclusion Criteria:

1. All participants must be 18 years or older.

2. All enrollees must understand and cooperate with requirements of the study and be able
to provide written informed consent

3. Individuals with medically stable mild to moderate Parkinson's disease or healthy
controls (as determined by enrolling investigator)

4. All participants must not have taken UDCA for 4 weeks prior to the study.

5. Absence of dementia in all subjects, as determined by pre-scanning cognitive
assessment.

Exclusion Criteria:

1. Inability to undergo MRI scanning without sedation and other MRI counterindications,
such as metal in the body.

2. Medically unstable conditions

3. Pregnant or lactating or those women of child-bearing age that are not using
acceptable forms of contraception

4. Unable to adhere to study protocol as determined by the PI



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: ursodeoxycholic acid
Primary Outcome(s)
Change in ATP concentration [Time Frame: prior to intervention and at 6 weeks of intervention]
Secondary Outcome(s)
UDCA pharmacokinetics [Time Frame: at 6 weeks of intervention]
Secondary ID(s)
1608M93041
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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