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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ubiquinol
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, ubiquinol, CoQ10, magnetic resonance spectroscopy, lactate, glutathione

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Ubiquinol

    Placebo

    Arm Description

    600mg ubiquinol daily for 24 weeks

    Placebo daily for 24 weeks

    Outcomes

    Primary Outcome Measures

    Number of Adverse Events
    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

    Cerebral Redox Markers
    Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy

    Full Information

    First Posted
    February 13, 2017
    Last Updated
    April 24, 2017
    Sponsor
    Weill Medical College of Cornell University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03061513
    Brief Title
    Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
    Official Title
    Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 28, 2012 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Weill Medical College of Cornell University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson Disease, ubiquinol, CoQ10, magnetic resonance spectroscopy, lactate, glutathione

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ubiquinol
    Arm Type
    Active Comparator
    Arm Description
    600mg ubiquinol daily for 24 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ubiquinol
    Intervention Description
    Ubiquinol caplets 600mg/day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Number of Adverse Events
    Description
    The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.
    Time Frame
    at 24 weeks
    Secondary Outcome Measure Information:
    Title
    Cerebral Redox Markers
    Description
    Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy
    Time Frame
    at baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claire Henchcliffe, MD DPhil
    Organizational Affiliation
    Weill Medical College of Cornell University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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