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Alzheimers Res Ther. 2014 Oct 08;6(5):67. doi: 10.1186/s13195-014-0067-0. eCollection 2014.

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.

Alzheimer's research & therapy

Nin Bajaj, Robert A Hauser, John Seibyl, Andreas Kupsch, Michail Plotkin, Chris Chen, Igor D Grachev

Affiliations

  1. National Parkinson's Foundation of Excellence, Nottingham University Hospitals NHS Trust and University of Nottingham, Derby Road, Nottingham NG7 2UH, UK.
  2. 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.
  3. The Institute for Neurodegenerative Disorders, 60 Temple St, New Haven 06510, CT, USA.
  4. Otto-von-Guericke-University, Leipziger Strasse 44, Magdeburg, 39120, Germany.
  5. Leiter des Vivantes Instituts für Nuklearmedizin Mitte/Nord, Landsberger Allee 49, Berlin, 10249, Germany.
  6. H2O Clinical LLC, 200 International Circle, Suite 5888, Cockeysville 21030, MD, USA.
  7. 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.

PMID: 25478029 PMCID: PMC4255542 DOI: 10.1186/s13195-014-0067-0

Abstract

INTRODUCTION: 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).

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