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Abstract

Objective:

To determine nonmotor signs (NMS) and evaluate the utility of several diagnostic tools in patients with de novo Parkinson disease (PD).

Methods:

This is a large single-center study of the DeNoPa cohort, including frequency-matched healthy controls. This study covers motor signs, NMS, and a combination of diagnostic tests including olfactory testing, transcranial sonography of substantia nigra (TCS), and polysomnography (PSG). We report the frequency and characteristics of NMS and the outcomes of nonmotor tests at the time of diagnosis.

Results:

Cross-sectional analyses of baseline investigations identified significant differences in the NMS Questionnaire (NMSQuest) and the Scopa-AUT Gastrointestinal score in 159 drug-naïve PD patients vs 110 controls. In addition, patients with PD showed reduced olfactory function, hyperechogenicity on TCS, and higher frequency of REM sleep behavior disorder (RBD). In exploring predictive markers, we found that the combination of several investigations, i.e., the NMSQuest, Scopa-AUT Gastrointestinal score, and Smell Identification Test reached an area under the receiver operating characteristic curve (AUC) of 0.913 (95% confidence interval [CI] 0.878–0.948). With the addition of serum cholesterol and mean heart rate values, the AUC value reached 0.919 (95% CI 886–0.953); when TCS and PSG were added, the AUC increased to 0.963 (95% CI 0.943–0.982).

Conclusions:

We show feasibility and utility of standardized data acquisition in a large, single-center cohort of patients with de novo PD and matched healthy controls. The baseline results from our prospective investigations reached a value of >0.9 sensitivity and specificity for biological markers when we added routine laboratory investigations and quantified nonmotor features including sleep.

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Supplementary Material

File (appendix_e-1.docx)
File (appendix_e-2.docx)

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Information & Authors

Information

Published In

Neurology®
Volume 81Number 14October 1, 2013
Pages: 1226-1234
PubMed: 23997153

Publication History

Received: March 28, 2013
Accepted: July 1, 2013
Published online: August 30, 2013
Published in print: October 1, 2013

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Disclosure

Dr. Mollenhauer has received speaker honoraria from Orion Corporation and GlaxoSmithKline; serves as an Associate Editor for the Journal of Alzheimer Disease; holds or has pending patents re: Method of differentially diagnosing dementias, Novel ELISA-based quantification of α-synuclein proteins in CSF and peripheral blood products using 384-well plates and MicroRNA expression profiling of CSF. She serves as a consultant for Bayer Schering Pharma AG and receives research support from Teva Pharmaceutical Industries Ltd., Desitin Pharmaceuticals, GmbH, Boehringer Ingelheim, GE Healthcare, the Michael J. Fox Foundation for Parkinson's Research, the American Parkinson's Disease Association, the Stifterverband für die Deutsche Wissenschaft (Dr. Werner Jackstädt-Stipend), and BMBF. Dr. Trautmann reports no disclosures. Dr. Sixel-Döring serves/has served on scientific advisory boards for Orion Corporation and Medtronic, Inc.; has received funding for travel from Boehringer Ingelheim; and has received speaker honoraria from Boehringer Ingelheim, Cephalon, Inc., Medtronic, Inc., Solvay Pharmaceuticals, Inc., UCB, and Orion Corporation. T. Wicke, Dr. Ebentheuer, M. Schaumburg, and E. Lang report no disclosures. Dr. Focke received funding from the Stifterverband für die Deutsche Wissenschaft (Dr. Werner Jackstädt-Stipend); served in an advisory board for GE Healthcare; and received honoraria from GlaxoSmithKline and travel support from UCB/Schwarz Pharma. Dr. Kumar has received a Movement Disorders Society Travel Grant (2012) and is a recipient of the National Health and Medical Research Council (NHMRC) of Australia Dora Lush Postgraduate Scholarship. Dr. Lohmann receives funding from the German Research Foundation. Dr. Klein is a member of the editorial board of Neurology® and has served as editor of the Continuum Issue Neurogenetics 2008 and as faculty at the annual meetings of the American Academy of Neurology since 2004. She has received consulting fees from Boehringer Ingelheim and Centogene and has received honoraria for speaking from Boehringer Ingelheim and Merz Pharma. She is the recipient of a career development award from the Hermann and Lilly Schilling Foundation. She is funded by the Volkswagen Foundation, the Deutsche Forschungsgemeinschaft, the Possehl Foundation, and received institutional support from the University of Luebeck for genetics research. Dr. Schlossmacher has received grants from the Michael J. Fox Foundation for Parkinson's Research, the Parkinson Research Consortium Ottawa, and the Government of Canada (CRC/CFI) and has served as an ad hoc, paid consultant for FoldRx, Genzyme Inc., Johnson & Johnson, Amicus Therapeutics, Elan Pharmaceuticals, Novartis Inc., and LINK Medicine. He has received lecture honoraria from Teva Neuroscience and has a scientific collaboration with Covance Inc, Epitomics Inc, and the Michael J. Fox Foundation. Dr. Kohnen has served on scientific advisory boards for UCB, Pfizer, and Mundipharma International Limited. T. Friede is an Associate Editor of Biometrical Journal and BMC Medical Research Methodology, a member of the Editorial Board of Therapeutic Innovation & Regulatory Science (formerly known as the Drug Information Journal), and an Academic Editor of PLOS One. He has acted or acts as a consultant to Novartis Pharma AG, Pharmalog Institut für Klinische Forschung GmbH, Biogen Idec, CSL Behring, Tibotec, and Schering Plough (Merck). He has received research funding from Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the Executive Agency for Health and Consumers. Dr. Trenkwalder serves on scientific advisory boards for Teva Pharma, Boehringer Ingelheim, UCB, Novartis, Mundipharma International Limited, and Britannia. She has received speaker honoraria from Boehringer Ingelheim, UCB, Novartis, and GlaxoSmithKline and serves on the editorial board and as guest editor of Sleep Medicine, CNS Drugs, and Movement Disorders. She receives research support from Teva Pharmaceutical Industries Ltd. and Mundipharma International Limited. Go to Neurology.org for full disclosures.

Study Funding

Supported by unrestricted research grants from the Paracelsus-Elena-Klinik, Kassel, Germany, and unrestricted research grants from TEVA Pharma/Lundbeck, GE Health care, and the Hermann und Lilly Schilling Foundation. The study sponsors provided support through an unrestricted grant and had no influence on the study design, collection and analysis of data, the writing of the paper, or the decision to submit the paper. The sponsors have been informed about the final manuscript and the submission for publication.

Authors

Affiliations & Disclosures

Brit Mollenhauer, MD*
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
speaker honoraria from Orion Corporation and GlaxoSmithKline
Editorial Boards:
1.
Associate Editor for the Journal of Alzheimer Disease (2011)
Patents:
1.
holds or has pending patents re: Method of differentially diagnosing dementias, Novel ELISA-based quantification of,-synuclein proteins in cerebrospinal fluid and peripheral blood products using 384-well plates and MicroRNA expression profiling of cerebrospinal fluid.
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
She serves as a consultant for Bayer Schering Pharma AG
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
receives research support from Teva Pharmaceutical Industries Ltd., Desitin Pharmaceuticals, GmbH, Boehringer Ingelheim, GE Healthcare.
Research Support, Government Entities:
1.
BMBF (01ED1203; BIOMARKAPD; PI, 2012-2015)
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Michael J. Fox Foundation for Parkinson's Research, (2) the American Parkinson's Disease Association and (3) the Stifterverband für die Deutsche Wissenschaft (Dr. Werner Jackstädt-Stipend)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Ellen Trautmann, PhD*
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Friederike Sixel-Döring, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
1) Advisory board for Orion Pharma since 2004 2) Advisory board for Medtronic Inc. in 2007
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
1) Travel to Movement Disorders Congress by Boehringer Ingelheim
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
Received fees for educational lectures by 1) Boehringer Ingelheim, 2) Cephalon, 3) Medtronic, 4)Solvay, 5)UCB, 6)Orion Corporation
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Tamara Wicke, MS
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Jens Ebentheuer, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Martina Schaumburg, MS
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Elisabeth Lang, BS
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Niels K. Focke, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
(1) GE Healthcare
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) GlaxoSmithKline (2) UCB/Schwarz Pharma
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Stifterverband für die Deutsche Wissenschaft (Dr. Werner Jackstädt-Stipend)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Kishore R. Kumar, PhD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
1. Movement Disorders Society Travel Grant (2012)
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
Recipient of the National Health and Medical Research Council (NHMRC) of Australia Dora Lush Postgraduate Scholarship.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Katja Lohmann, PhD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
University of Luebeck
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
German Research Foundation(DFG; LO1555/3-2; LO1555/4-1)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Christine Klein, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Speaker honoraria by Glaxo Smith Kline and Shire.
Editorial Boards:
1.
Neurology Movement Disorders Parkinson's Disease
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
AAN, participation in teaching courses as faculty and course director (since 2004)
Consultancies:
1.
Centogene, consultant, since 2008 Link Medicine, consultant in 2010/2011
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
German Research Foundation (support since 1997)
Research Support, Academic Entities:
1.
Intramural funding from the University of Luebeck for various research projects (since 2000)
Research Support, Foundations and Societies:
1.
Volkswagen Foundation, career development award, 2005 - 2010 Hermann and Lilly Schilling Foundation, career development award, since 2009 DFG and Fritz Thyssen Foundation, research support since 2000
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Michael G. Schlossmacher, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
Not for profit: Parkinson Society Canada
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Non-profit: International Synuclein Conference Dubai 2012
Editorial Boards:
1.
NONE
Patents:
1.
Patent: Treatment of synucleinopathy; issued by USPTO on June 4th, 2013
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Academic institute: 100%
Consultancies:
1.
For profit: Jan 2013: Bristol-Myers Scribb
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
Government of Canada: 1) Canada Research Chair Program (PI: 2011-2016); 2)Canadian Institutes of Health Research (PI: 2010-2015);
Research Support, Academic Entities:
1.
University of Ottawa Brain and Mind Research Institute (2013-2014)
Research Support, Foundations and Societies:
1.
Michael J Fox Foundation for Parkinson's Research (PI: 2013-2015);
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
Patent: Co-inventor for the Treatment of Synucleinopathies. IP resides with Brigham and Women's Hospital, Boston, MA.
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Ralf Kohnen, PhD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
Ralf Kohnen has served on scientific advisory boards for UCB, Pfizer and Mundipharma International Limited.
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Tim Friede, PhD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
(1) Biometrical Journal, Editor, 2009-2011 (2) Biometrical Journal, Associate Editor, since 2012 (3) BMC Medical Research Methodology, since 2011 (4) PLOS ONE, Academic Editor, since 2013 (5) Therapeutic Innovation & Regulatory Science (formerly known as Drug Information Journal), Editorial Board, since 2003
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
(1) Novartis Pharma AG, consultant, since 2007 (2) Pharmalog Institut für Klinische Forschung GmbH, consultant, since 2006 (3) Biogen Idec, consultant, 2012-2013 (4) CSL Behring, consultant, 2010-2011 (5) Tibotec, DMC member, since 2008 (6) Schering Plough (Merck), DMC member, 2009-2010
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
(1) Deutsche Forschungsgemeinschaft, Principal investigator, FR-3070/1-1, 2012-2015 (2) Bundesministerium für Bildung und Forschung, Principal investigator, 13 6406 0, 2011-2015 (3) Executive Agency for Health and Consumers, Principal investigator, 2010 12 13, 2011-2014
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Claudia Trenkwalder, MD
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.
Disclosure
Scientific Advisory Boards:
1.
Boehringer Ingelheim, UCB, Mundipharma, Orion, Ever Neuro Pharma,Novartis, Teva, Desitin, GSK, Britannia Pharmaceuticals, RPS ResearchBoehringer Ingelheim
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Speaker honoraria from: Boehringer Ingelheim, UCB, Mundipharma, Orion, Ever Neuro Pharma,Novartis, Teva, Desitin, GSK, Britannia Pharmaceuticals, RPS Research
Editorial Boards:
1.
Sleep Medicine, Editorial Board member, 2004 until now Movement Disorders, Editorial Board Member, 2007-2011, CNS Editor
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Employment as medical director of the Paracelsus-Elena Hospital, Kassel
Consultancies:
1.
Novartis UCB Mundipharma
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
TEVA research grant for 2 years Michel J.Fox Grant
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
All disclosed above under 1. and 3., no additional payments received
On behalf of the DeNoPa Study Group
From the Center of Parkinsonism and Movement Disorders (B.M., E.T., F.S.-D., T.W., J.E., M.S., E.L., C.T.), Paracelsus-Elena-Klinik, Kassel; Department of Neurosurgery (B.M., N.K.F., C.T.), University Medical Centre, Goettingen; Department of Psychology (E.T.), University Kassel; Section of Clinical and Molecular Neurogenetics at the Department of Neurology (K.R.K., K.L., C.K.), University of Luebeck; Departments of Neuropathology (B.M.) and Medical Statistics (T.F.), University Medical Centre, Goettingen, Germany; Program in Neuroscience (M.G.S.), Ottawa Hospital Research Institute; Division of Neurology, The Ottawa Hospital, University of Ottawa, Canada; and ReSearch Pharmaceutical Services (R.K.), Nuremberg, Germany.

Notes

Correspondence to Dr. Mollenhauer: [email protected]
*
These authors contributed equally to this work.
DeNoPa coinvestigators are listed on the Neurology® Web site at www.neurology.org.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

B.M., F.S.D., and C.T. designed the study and were responsible for recruitment and data processing. E.T. and T.F. oversaw all statistical analyses. T.W., J.E., E.T., M.S., E.L., and N.K.F. were responsible for performing investigations and collecting and entering data. K.R.K., K.L., and C.K. performed genetic analyses and assisted in data interpretation. N.K. and M.G.S. were involved in sample analyses and data interpretation. C.T. oversaw patient recruitment and characterization and assisted in the interpretation of data. B.M., C.T., and E.T. wrote the manuscript. F.S.-D., M.G.S., T.F., C.K., R.K., and K.L. coedited the manuscript. B.M., C.T., and F.S.-D. had full access to the clinical primary data. B.M. and E.T. have full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors had access to the data generated in the study including the statistical analysis and decided to submit the paper for publication.

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