G20
Conditions
Interventions
Group 1: 156 mg QuinoMit Q10 fluid (equivalent dosage of 1200 mg Coenzym Q10) ubiquinon emulsion, 8 strokes tid (five hour gap between each intake, e.g. at 8 am 1pm, and 6pm) for an intervention perio
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: PD diagnosis based on UK Brain Bank criteria genotyping and assignment to regarding study group stable PD mediaction (for at least 4 weeks) age above or equal to 18 years written informed consent
Exclusion criteria
Exclusion criteria: comorbidities that impair giving informed consent (severe dementia [MMSE<24], psychosis, severe depression) atypical or secondary parkinsonism pregnancy, breastfeeding or current wish for pregnancy no contraception, unless the patient is in her menopause (self-)treatment with coenzyme Q10 up to 3 months before trial enrollment known intolerance or allergy to conenzyme Q10 concomitant medication with thyroid drugs concomitant medication with vitamine K anatgonists concomitant medication with betablockers epilepsy structural brain damage (e. g. following stroke) allergy to soy concomitant participation in another clinical trial (besides pure questionnaire-based trials or vitamine K2 interventional trials) within the last 30 days prior to study enrollment known severe liver or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of motor symptoms of Parkinson's disease patients following a 6 months intervention period. The primary endpoint will be the difference between the motor subscale of the revised "Unified Parkinson's Disease Rating Scale" (MDS-UPDRS) between baseline visit and after 6 months post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| changes from the baseline visit in the following scales 1.) MDS-UPDRS-III motor subscale (after 3 and 9) months 2.) MDS-UPDRS-I (after 3, 6, and 9 months) 3.) Activities of daily living MDS-UPDRS-II (after 3, 6, and 9 months) 4.) combined sum score based on the "Timed up and Go-Test", "10-meter walk test", and "finger tapping task" (taken from the MDS-UPDRS-III) (after 3, 6, and 9 months) 5.) Quality of life bassed on the PDQ39 (after 3, 6, and 9 months) 6.) Depression as measured by the BDI II (after 3, 6, and 9 months) 7.) MDS-UPDRS-IV (after 3, 6, and 9 months) 8.) cognitive impairment as measured by Montreal Cognitive Assessment (after 3, 6, and 9 months) 9.)Fatigue Severity Scale (FSS) (after 3, 6, and 9 months) 10.) changes in brain metabolism (as measured via magnetic resonance spectroscopy) of PCr/inorganic phosphate (Pi) in Q10 treated patients (after 6 months) 11.) changes in brain metabolism (as measured via magnetic resonance spectroscopy) of ATP/Pi in Q10 treated patients (after 6 months) 12.) changes of structural MRI measures (based on DWI/DTI) (after 6 months) 13.) changes of structural MRI measures (based on measures of iron depositon/SWI) (after 6 months) 14.) changes of functional (resting state) MRI measures (of motor networks) (after 6 months) | — |
Countries
Germany
Contacts
Public ContactElena Löwin
Institut für NeurogenetikUniversität zu Lübeck
Outcome results
None listed