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Abstract

Objective:

To compare the clinical and imaging characteristics of those PRECEPT (Parkinson Research Examination of CEP-1347 Trial) subjects with a scan without evidence of dopaminergic deficit (SWEDD) to those with dopamine transporter (DAT) deficit scans at study baseline and during a 22-month follow-up.

Methods:

Baseline (n = 799) and 22-month follow-up (n = 701) [123I] β-CIT SPECT scans were acquired. The percent change in [123I] β-CIT striatal binding ratio, the percentage of subjects requiring dopaminergic therapy, the change in Unified Parkinson's Disease Rating Scale (UPDRS) score, and the PRECEPT Study investigators’ diagnosis at study termination were compared between SWEDD and DAT deficit subjects.

Results:

SWEDD subjects (n = 91) compared with DAT deficit subjects (n = 708) showed reduced UPDRS score at baseline (18.7 [SD 8.5] vs 25.5 [SD 10.5], p < 0.05) and minimal change in both [123I] β-CIT striatal binding ratio (−0.2% [SD 12.2] vs −8.5% [SD 11.9], p < 0.0001) and UPDRS score (0.5 [SD 6.9] vs 10.5 [SD 8.9], p < 0.0001) at follow-up assessments. At PRECEPT termination, the diagnosis by study investigators was changed from Parkinson disease (PD) to other disorders not associated with DAT deficit in 44% (95% confidence interval 34.2, 54.7) of SWEDD subjects compared with 3.6% (95% confidence interval 2.3, 5.1) of DAT deficit subjects.

Conclusion:

These results indicate that subjects identified as having a SWEDD, with DAT imaging within the normal range, have minimal evidence of clinical or imaging PD progression. These data strongly suggest that SWEDD subjects are unlikely to have idiopathic PD.

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Supplementary Material

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Information & Authors

Information

Published In

Neurology®
Volume 82Number 20May 20, 2014
Pages: 1791-1797
PubMed: 24759846

Publication History

Received: July 16, 2012
Accepted: February 19, 2014
Published online: April 23, 2014
Published in print: May 20, 2014

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Disclosure

K. Marek holds ownership interest in Molecular NeuroImaging, LLC; has served as a paid consultant for GE Healthcare, Bayer Healthcare, Eli Lilly, Sanofi, Merck Serono, AstraZeneca, Prothena, nLife, BMS, Pfizer, and Merck; and holds grants with the Department of Defense and The Michael J. Fox Foundation for Parkinson's Research. J. Seibyl reports that he holds equity interest in Molecular NeuroImaging, LLC; has served as a consultant for GE Healthcare; holds grants from the Department of Defense; and has received payment for the development of educational presentations from Bayer Healthcare. S. Eberly and D. Oakes report no disclosures relevant to the manuscript. I. Shoulson reports that he received support for travel to study meetings from Cephalon, Inc.; serves on the board as associate editor for Archives of Neurology; is a paid consultant for the Archives of Neurology, the RJG Foundation, Partners Health Care, Link Medicine, Merck Serono SA, NIH Treasury, Medtronic, Lundbeck, Inc., Salamandra, LLC, Washington University, Adolor Corporation, The Michael J. Fox Foundation for Parkinson's Research, Montefiore Medical Center, Goodwin Proctor, CSL Ltd., Prana Biotechnology, New York University, University of Tennessee, Alkermes, Duke University, Ovation, Cornell University, the American Academy of Neurology, MSI Methylation Sciences, NuPathe, Inc., Auspex Pharma, Seneb BioSciences, Inc., Isis Pharmaceuticals, Edison Pharmaceuticals, Johns Hopkins University, Johnson & Johnson, Omeros Corporation, Knopp Biosciences, LLC, Clarion Healthcare, and Polaris Venture Partners; and holds current or pending grants with the Food and Drug Administration, the Parkinson Disease Foundation, and Johns Hopkins University. A. Lang reports no disclosures relevant to the manuscript. C. Hyson reports no disclosures relevant to the manuscript. D. Jennings is an employee of Molecular NeuroImaging, LLC; has received money for a consultancy with Teva; holds and has pending grants with The Michael J. Fox Foundation for Parkinson's Research; and has received payments for lectures from the American Pharmacists Association and the Movement Disorders Society. Authors of this report from the Parkinson Study Group (PSG) received grant support from the sponsors through their academic institutions (coinvestigator appendix on the Neurology® Web site at Neurology.org), but they neither had equity interests in nor received any personal remuneration from the sponsoring companies since initiation of the study. Some authors of the report are employees of the sponsor and are so designated in the coinvestigator appendix. The PSG maintained the PRECEPT database and performed independent analysis of the data. Go to Neurology.org for full disclosures.

Study Funding

Supported by Cephalon, Inc. (Frazer, PA) and H. Lundbeck A/S (Copenhagen and Valby, Denmark). Supported in part by DOD W81XWH-05-1-0603 at the Institute for Neurodegenerative Disorders.

Authors

Affiliations & Disclosures

Kenneth Marek, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
(1) Michael J Fox Foundation (2) Shire Pharmaceutical
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.
(1) Pfizer (2)GE Healthcare (3)Merck (4) Eli Lilly (5)BMS (6) Piramal (7)Prothena (8)Neurophage, (9) nLife, (10)Roche
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) DOD �TATRC, W81XWH-06-1-0678, Principal Investigator, 10/1/06 � 09/30/15
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) MJFox Foundation, Parkinson progression marker intiative, Principal Investigator, 6/15/09 � 6/14/18 (2) MJFox Foundation, DAT imaging in LRKKS family members, Principal Investigator, 1/15/10 � 1/14/15
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.
(1) Equity interest in Molecular NeuroImaging, LLC (2001-present)
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
John Seibyl, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
Roche GE Healthcare
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.
Molecular Neuroimaging
Consultancies:
1.
Piramal Navidea
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.
MJ Fox Foundation
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.
Ownership- Molecular Neuroimaging
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Shirley Eberly, MS
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
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.
1) Commercial entity: Biogen Idek 2) Commercial entity: Auspex Pharmaceuticals
Research Support, Government Entities:
1.
1) Subaward from MGH, Steven Hersch: 10/1/2010-8/31/2015: Blood Level of Huntington�s: A Biomarker of Huntington�s Disease; UO1NS071789 is NIH award number. Data analysis. 2) Subaward from Harvard, Alberto Ascherio: 4/15/2009-3/31/2014: Urate as a Predictor of Parkinson�s Disease Risk and Progression; RO1NS061858 is NIH award number. Data analysis. 3) University of Rochester, Mark W. Frampton: 4/1/2009-3/31/2014: Ozone Cardiovascular Effects in Genetically Susceptible People; RO100513195 is NIH award number. Data analysis.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
Michael J Fox Foundation
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
David Oakes, PhD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Editor, Lifetime Data Analysis, 2010-present
Patents:
1.
NONE
Publishing Royalties:
1.
Royalties Cox DR and Oakes D Analysis of Survival Data, Chapman and Hall, 1984
Employment, Commercial Entity:
1.
University of Rochester Professor
Consultancies:
1.
Novo Nordisk Inc Sanofi Inc Vanda Pharmaceuticals
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.
NINDS U01 NS050573, PI, 2005-2012
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
Ira Shoulson, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
Chair, Data Safety Monitoring Board for EPI743 in Leigh Syndrome and Friedreich Ataxie (Edison Pharmaceuticals) 2012-present Michael J. Fox Foundation (2012-present) NINDS NeuroNEXT Exec Oversight Board Mtg (2013) Lundbeck Advisory Board (2013)
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Lundbeck Advisory Board Meeting (2011-2013), QE3 DSMB Meeting NYC (2012), National Academies SSA Meeting (2012-2013), Michael J Fox Foundation SAB meeting (2012), Archives of Neurology Editorial Board Meeting NYC (2012-2013), Shire HGT LLC meeting in Boston (2012), Impax Advisory Brd Meeting Miami FL (2012),Prana Biotechnology Advisory Meeting (2013), Genzyme Corporation Mock Panel in Boston (2013), Chelsea Therapeutics Mock Panel Meeting in Charlotte, NC (2013), Omeros Corp Meeting in Chicago (2013)
Editorial Boards:
1.
JAMA Neurology, Assoc Editor, current Journal of Parkinson Disease, Editorial Board, current Journal of Huntington Disease, Editorial Board, current Neuropharmacology, Editorial Board, current NeuroTherapeutics, Chair, Oversight Committee
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Georgetown University
Consultancies:
1.
Receive consultng fees from: Alkermes, Inc. (2011-2012), AstraZeneca (2011), Auspex Pharmaceuticals (2011-2014), AZTherapies (2013), Biogen Idec (2012), Caravel Group (2013), Chelsea Therapeutics (2013), Clarion Healthcare Consulting, LLC (2012), Edison Pharmaceuticals(2011-2013), Genzyme (2013), Impax Pharmaceuticals (2012), Ipsen Pharmaceuticals (2012), Isis Pharmaceuticals (2011), Johnson & Johnson (2011-2012), Knopp Biosciences LLC (2012), Link Medicine Corp (2011), Lundbeck (2011-2013), Medtronic Inc. (2012), NeuroGlobe (2013), NeuroSearch Optio Biotech Solutions(2011), Omeros Corporation (2012-2013), Orphazyme APS (2013), Partners Healthcare (2011-2013), Pick Research Solutions (2013), Prana Biotechnology (2011-2013), RJG Foundation (2011), Salamandra LLC (2013), Seneb Bioscience Inc.(2011-2013), Shire Human Genetic Therapies (2011), Sofinnova Venture Partners (2013, Third Rock Ventures (2013), Velocity Pharmaceutical Development (2013)
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
Speaker at Update in Neurology Conference, Georgetown University Conference (2012) Innovations Consulting Group LLC - Honoraria: ACTTION Board of Advisors
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Parkinson Disease Foundation (2011-2013) Johns Hopkins University (2012-2013) CHDI Management Inc. (2004-2012)
Research Support, Government Entities:
1.
Food and Drug Administration (FDA) 1U01FD004319-01, PI (2011-2014) NIH/NINDS/NHGRI R01HG02449 (2002-2012) NIH 1R01NS50324-01A1 (2005-2012) University of California, Irvine CIRM Grant No. TR201841, Consultant (2012-2014)
Research Support, Academic Entities:
1.
American Academy of Neurology speaking at Plenary Session Honolulu, HI, Speaking/Presenting at Neuro Challenge Foundation Sarasota, FL (2011), Johns Hopkins University Cohen Lecture (2012),University of Rochester (2013)
Research Support, Foundations and Societies:
1.
Michael J Fox Foundation Scientific Advisory Board Meeting honorarium (2011 & 2012)
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
Anthony E. Lang, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
Abbott, Abbvie, Allon Therapeutics, Avanir Pharmaceuticals, Biogen Idec, Boerhinger-Ingelheim, Ceregene, Lilly, Medtronic, Merck, Novartis, NeuroPhage Pharmaceuticals, Teva and UCB.
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Teva, AbbVie, UCB
Editorial Boards:
1.
Movement Disorders:Clinical Practice Journal of Neurology, Neurosurgery and Psychiatry
Patents:
1.
NONE
Publishing Royalties:
1.
Schapira A, Lang AE, Fahn S. Movement Disorders 4. Saunders, Elsevier, Philadelphia, PA 2009. Olanow CW, Stocchi F, Lang AE. The Non-motor and Non-Dopaminergic Features of Parkinson�s Disease. Wiley-Blackwell, UK. 2011. Weiner WJ, Shulman LM, Lang AE. Parkinson�s Disease: A Complete Guide for Patients and Families. The Johns Hopkins University Press, Baltimore. 2001 Receives publishing royalties from Cambridge University Press.
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.
Brain Canada, Canadian Institutes of Health Research Ontario Brain Institute
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
Edmond J Safra Philanthropic Foundation, Michael J. Fox Foundation, National Parkinson Foundation, Parkinson Society Canada, Tourette Syndrome Association, W. Garfield Weston Foundation
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.
Has served as an expert witness in cases related to the welding industry.
Chris Hyson, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
1. Biogen, Tysabri Advisory Board, 2008-2010
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Merz Pharmaceuticals, speaker honoraria (2) Biogen Pharmaceuticals, speaker honoraria (3) Allergan, speaker honoraria
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
1. Biogen, speaking engagement on MS + Tysabri, 2009 2. Biovail/Prestwick, speaking engagement on Tardive Dyskensia, 2009
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
Danna Jennings, MD
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Novartis speaker honorarium
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Employed by Molecular NeuroImaging
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
For The Parkinson Study Group PRECEPT Investigators
From the Institute for Neurodegenerative Disorders (K.M., J.S., D.J.), University of Rochester (S.E., D.O.), Rochester, NY; Georgetown University (I.S.), Washington, DC; University of Toronto (A.E.L.); and Western University (C.H.), London, Ontario, Canada.

Notes

Correspondence to Dr. Marek: [email protected]
Parkinson Study Group PRECEPT coinvestigators are listed on the Neurology® Web site at 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

Kenneth Marek: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, acquisition of data, study supervision, obtaining funding. John Seibyl: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, acquisition of data, study supervision. Shirley Eberly: drafting/revising the manuscript, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, statistical analysis. David Oakes: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, statistical analysis. Ira Shoulson: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, obtaining funding. Anthony E. Lang: drafting/revising the manuscript, analysis or interpretation of data, accepts responsibility for conduct of research and will give final approval, acquisition of data. Chris Hyson: drafting/revising the manuscript, study concept or design, accepts responsibility for conduct of research and will give final approval, acquisition of data, study supervision. Danna Jennings: drafting/revising the manuscript, study concept or design, accepts responsibility for conduct of research and will give final approval, acquisition of data, study supervision.

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