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

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ClinicalTrials.gov Identifier: NCT03061513
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Ubiquinol Dietary Supplement: Placebo Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
Actual Study Start Date : February 28, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ubiquinol
600mg ubiquinol daily for 24 weeks
Drug: Ubiquinol
Ubiquinol caplets 600mg/day
Placebo Comparator: Placebo
Placebo daily for 24 weeks
Dietary Supplement: Placebo
placebo



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: at 24 weeks ]
    The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.


Secondary Outcome Measures :
  1. Cerebral Redox Markers [ Time Frame: at baseline and 8 weeks ]
    Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061513


Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Claire Henchcliffe, MD DPhil Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03061513     History of Changes
Other Study ID Numbers: 1112012060
First Posted: February 23, 2017    Key Record Dates
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
Parkinson Disease
ubiquinol
CoQ10
magnetic resonance spectroscopy
lactate
glutathione

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs