Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers

Parkinson Disease Clinical Trial

Official title:

Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061513
• Other study ID #: 1112012060
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2017
• Last updated: February 17, 2017
• Start date: February 28, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic resonance spectroscopy (MRS) and blood test for biological markers taken during the study.

Description:

Multiple lines of evidence have implicated abnormal energy metabolism and deficient mitochondrial function in Parkinson's disease, presenting a unique target for therapy. A pilot study of ubiquinol in PD was therefore undertaken to determine its effects upon physiologic measures of mitochondrial metabolic function. The incorporation of a neuroimaging biomarker is particularly important, since changes would demonstrate our ability to achieve Central Nervous System (CNS) access from this an formulation, accompanied by a meaningful neurophysiologic effect. Hydrogen Proton Magnetic Resonance Spectroscopy Imaging (1H MRSI) is a technique that provides insight into the metabolism of several endogenous brain compounds, most notably N-acetyl-L-aspartate (NAA), choline-containing compounds (Cho), and creatine and phosphocreatine (Cr). A number of studies of mitochondrial function have now firmly established the utility of 1H MRSI in probing potential mitochondrial energy metabolism dysfunction, in primary mitochondrial disorders, but also in PD. This pilot study is therefore designed to test whether oral ubiquinol affects cerebral indices of mitochondrial dysfunction, as measured by 1H MRSI in patients with Parkinson's disease, and to gather preliminary information on the safety and tolerability of ubiquinol in individuals with PD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• diagnosis of PD according to the Untied Kingdom (UK) Brain Bank Criteria, and confirmed by a Movement Disorders neurologist;

• age 40-75 years; diagnosis within 5 years of study participation;

• PD medications able to remain at stable doses in the opinion of the enrolling investigator;

• able to undergo MRI;

• absence of significant medical, psychiatric, and other neurological disease;

• absence of dementia and Mini-Mental State Examination (MMSE) > 26.

Exclusion Criteria:

• failure to meet diagnosis by above criteria;

• time since diagnosis > 5 years before study participation;

• PD medications not predicted to remain at stable doses in the opinion of the enrolling investigator;

• unable to undergo MRI;

• unable to comply with informed consent process;

• presence of significant medical, psychiatric (including major depressive disorder) or other neurological (including epilepsy, brain tumor, stroke) disease;

• diagnosis of dementia and/or MMSE 26 or lower;

• possibility of pregnancy (negative test required in women of childbearing age);

• taking medications including antipsychotic agents and dopamine- blocking anti-emetic agents;

• taking Coenzyme Q10;

• participation in another clinical trial within the last 3 months.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Ubiquinol
Ubiquinol caplets 600mg/day

Dietary Supplement:
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of adverse effects	The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.	at 24 weeks
Secondary	Clinical assessment	UPDRS in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period	at baseline, 8 and 24 weeks
Secondary	Cerebral redox markers	Cerebral lactate levels as determined by Magnetic Resonance Spectroscopy	at baseline and 8 weeks