title: Association between Hoehn and Yahr, Mini-Mental State Examination, age, and clinical syndrome predominance and diagnostic effectiveness of ioflupane I 123 injection (DaTSCAN™) in subjects with clinically uncertain parkinsonian syndromes.
abstract: BACKGROUND
  Diagnostic effectiveness of Ioflupane I 123 injection (DaTSCAN™, DaTscan™, or [123I]FP-CIT or ioflupane [(123)I]) SPECT imaging, was assessed in patients with clinically uncertain parkinsonian syndrome (CUPS).
  
  
  METHODS
  We investigated the association between subject's Hoehn & Yahr (H&Y) stage, Mini-Mental State Examination (MMSE), age, and motor symptom subgroups and diagnostic performance of ioflupane [(123)I] imaging. Phase 4 study data were used to calculate sensitivity, specificity, positive and negative predictive value, and accuracy in 92 CUPS subjects, using 1-year clinical diagnosis after ioflupane [(123)I] imaging as reference standard.
  
  
  RESULTS
  Diagnostic effectiveness of ioflupane [(123)I] imaging was high in all subgroups: 91% to 100% for H&Y low (<2) and high (≥2) stage subjects; 93% to 96% for MMSE low (<29) or high (≥29) scores; 91% to100% in both age subgroups (younger [<68] and older [≥68]); and 92% to 100% in subjects with both tremor dominant and balanced motor signs. Specificity of ioflupane [(123)I] imaging for bradykinetic rigid or posturally (BRP) unstable motor subtype was lower, but better than for baseline clinical diagnosis.
  
  
  CONCLUSIONS
  Strongest diagnostic performance of ioflupane [(123)I] imaging for clinical diagnosis of Parkinson's syndrome (PS) or non-PS was associated with tremor and balanced motor dominance rather than with BRP dominance. High diagnostic effectiveness of ioflupane [(123)I] imaging and favourable performance relative to final clinical diagnosis at 1 year post-scan in subjects with CUPS was demonstrated. This study suggests that the diagnostic performance of ioflupane [(123)I] imaging in CUPS remains high at all stages of disease, including early stage, and across both age groups and cognitive state (MMSE).
authors.affiliation: National Parkinson's Foundation of Excellence, Nottingham University Hospitals NHS Trust and University of Nottingham, Derby Road, Nottingham NG7 2UH, UK.
authors.forename: Nin
authors.initials: N
authors.lastname: Bajaj
authors.affiliation: USF Parkinson's Disease and Movement Disorders Center, National Parkinson Foundation Center of Excellence, USF Health - Byrd Institute, 4001 E. Fletcher Ave, 6th Floor, Tampa 33613, FL, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hauser
authors.affiliation: The Institute for Neurodegenerative Disorders, 60 Temple St, New Haven 06510, CT, USA.
authors.forename: John
authors.initials: J
authors.lastname: Seibyl
authors.affiliation: Otto-von-Guericke-University, Leipziger Strasse 44, Magdeburg, 39120, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kupsch
authors.affiliation: Leiter des Vivantes Instituts für Nuklearmedizin Mitte/Nord, Landsberger Allee 49, Berlin, 10249, Germany.
authors.forename: Michail
authors.initials: M
authors.lastname: Plotkin
authors.affiliation: H2O Clinical LLC, 200 International Circle, Suite 5888, Cockeysville 21030, MD, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Chen
authors.affiliation: Medical Affairs, GE Healthcare - Life Sciences, 101 Carnegie Center, Princeton NJ 08540, New Jersey, USA ; Presently: Novartis Consumer Health, Parsippany, New Jersey, USA ; Presently: Genpact Pharmalink, Short Hills, New Jersey, USA.
authors.forename: Igor D
authors.initials: ID
authors.lastname: Grachev