The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design
Background: Despite rapid advances in research on Parkinson's disease (PD), in particular in the elucidation of genetic contributions, no disease-modifying therapy has become available to date.Objectives: In the proposed project, we aim to investigate the potential effects of vitamin K2 (long-c...
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doaj-3b224e2f044a4491ba142a2d45d7a8b82021-01-11T04:39:13ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-01-011110.3389/fneur.2020.592104592104The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group DesignJannik Prasuhn0Jannik Prasuhn1Meike Kasten2Meike Kasten3Melissa Vos4Inke R. König5Sebastian M. Schmid6Sebastian M. Schmid7Britta Wilms8Britta Wilms9Christine Klein10Norbert Brüggemann11Norbert Brüggemann12Institute of Neurogenetics, University of Lübeck, Lübeck, GermanyDepartment of Neurology, University Medical Center Schleswig-Holstein, Lübeck, GermanyInstitute of Neurogenetics, University of Lübeck, Lübeck, GermanyDepartment of Psychiatry and Psychotherapy, University Medical Center Schleswig-Holstein, Lübeck, GermanyInstitute of Neurogenetics, University of Lübeck, Lübeck, GermanyInstitute of Medical Biometry and Statistics, University of Lübeck, Lübeck, GermanyInstitute of Endocrinology and Diabetes, University of Lübeck, Lübeck, GermanyGerman Center for Diabetes Research (DZD), Neuherberg, GermanyInstitute of Endocrinology and Diabetes, University of Lübeck, Lübeck, GermanyGerman Center for Diabetes Research (DZD), Neuherberg, GermanyInstitute of Neurogenetics, University of Lübeck, Lübeck, GermanyInstitute of Neurogenetics, University of Lübeck, Lübeck, GermanyDepartment of Neurology, University Medical Center Schleswig-Holstein, Lübeck, GermanyBackground: Despite rapid advances in research on Parkinson's disease (PD), in particular in the elucidation of genetic contributions, no disease-modifying therapy has become available to date.Objectives: In the proposed project, we aim to investigate the potential effects of vitamin K2 (long-chain menaquinone 7, MK-7) in genetically determined PD with mitochondrial dysfunction.Methods: A total of 130 study participants (26 biallelic Parkin/PINK1 mutation carriers, 52 sporadic PD patients, and 52 healthy controls) will receive the trial medication (MK-7 or placebo for 1 week). 31P-Magnetic resonance spectroscopy imaging of the forebrain and basal ganglia (31P-MRSI, primary endpoint) as well as other advanced neuroimaging methods, clinical assessment, including quantitative movement analysis, and biomarker sampling will be applied pre- and post-intervention.Innovation: The proposed project is highly translational as it builds on compelling mechanistic data from animal studies as well as on a small preliminary data set in humans. Patients are selected based on their mutation-related mitochondrial dysfunction and compared to disease and a healthy control group in a personalized medicine approach. We will further investigate how neuroimaging and blood-derived biomarkers can predict individual treatment response in sporadic PD.Clinical trial registration: This study was registered at the German Clinical Trial Registry (DRKS, DRKS00019932) on the 19th of December 2019.https://www.frontiersin.org/articles/10.3389/fneur.2020.592104/fullParkinson's diseasetreatmentsvitamin K2Parkin (PARK2)PINK1 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jannik Prasuhn Jannik Prasuhn Meike Kasten Meike Kasten Melissa Vos Inke R. König Sebastian M. Schmid Sebastian M. Schmid Britta Wilms Britta Wilms Christine Klein Norbert Brüggemann Norbert Brüggemann |
spellingShingle |
Jannik Prasuhn Jannik Prasuhn Meike Kasten Meike Kasten Melissa Vos Inke R. König Sebastian M. Schmid Sebastian M. Schmid Britta Wilms Britta Wilms Christine Klein Norbert Brüggemann Norbert Brüggemann The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design Frontiers in Neurology Parkinson's disease treatments vitamin K2 Parkin (PARK2) PINK1 |
author_facet |
Jannik Prasuhn Jannik Prasuhn Meike Kasten Meike Kasten Melissa Vos Inke R. König Sebastian M. Schmid Sebastian M. Schmid Britta Wilms Britta Wilms Christine Klein Norbert Brüggemann Norbert Brüggemann |
author_sort |
Jannik Prasuhn |
title |
The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design |
title_short |
The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design |
title_full |
The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design |
title_fullStr |
The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design |
title_full_unstemmed |
The Use of Vitamin K2 in Patients With Parkinson's Disease and Mitochondrial Dysfunction (PD-K2): A Theranostic Pilot Study in a Placebo-Controlled Parallel Group Design |
title_sort |
use of vitamin k2 in patients with parkinson's disease and mitochondrial dysfunction (pd-k2): a theranostic pilot study in a placebo-controlled parallel group design |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Neurology |
issn |
1664-2295 |
publishDate |
2021-01-01 |
description |
Background: Despite rapid advances in research on Parkinson's disease (PD), in particular in the elucidation of genetic contributions, no disease-modifying therapy has become available to date.Objectives: In the proposed project, we aim to investigate the potential effects of vitamin K2 (long-chain menaquinone 7, MK-7) in genetically determined PD with mitochondrial dysfunction.Methods: A total of 130 study participants (26 biallelic Parkin/PINK1 mutation carriers, 52 sporadic PD patients, and 52 healthy controls) will receive the trial medication (MK-7 or placebo for 1 week). 31P-Magnetic resonance spectroscopy imaging of the forebrain and basal ganglia (31P-MRSI, primary endpoint) as well as other advanced neuroimaging methods, clinical assessment, including quantitative movement analysis, and biomarker sampling will be applied pre- and post-intervention.Innovation: The proposed project is highly translational as it builds on compelling mechanistic data from animal studies as well as on a small preliminary data set in humans. Patients are selected based on their mutation-related mitochondrial dysfunction and compared to disease and a healthy control group in a personalized medicine approach. We will further investigate how neuroimaging and blood-derived biomarkers can predict individual treatment response in sporadic PD.Clinical trial registration: This study was registered at the German Clinical Trial Registry (DRKS, DRKS00019932) on the 19th of December 2019. |
topic |
Parkinson's disease treatments vitamin K2 Parkin (PARK2) PINK1 |
url |
https://www.frontiersin.org/articles/10.3389/fneur.2020.592104/full |
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