TY  - JOUR
AU  - Höglinger, Günter U
AU  - Schöpe, Jakob
AU  - Stamelou, Maria
AU  - Kassubek, Jan
AU  - Del Ser, Teodoro
AU  - Boxer, Adam L
AU  - Wagenpfeil, Stefan
AU  - Huppertz, Hans-Jürgen
AU  - Investigators, AL-108-231
AU  - Investigators, Tauros MRI
AU  - Group, Movement Disorder Society-Endorsed PSP Study
TI  - Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials.
JO  - Movement disorders
VL  - 32
IS  - 6
SN  - 0885-3185
CY  - New York, NY
PB  - Wiley
M1  - DZNE-2020-05636
SP  - 842-852
PY  - 2017
AB  - Two recent, randomized, placebo-controlled phase II/III trials (clinicaltrials.gov: NCT01110720, NCT01049399) of davunetide and tideglusib in progressive supranuclear palsy (PSP) generated prospective, 1-year longitudinal datasets of high-resolution T1-weighted three-dimensional MRI.The objective of this study was to develop a quantitative MRI disease progression measurement for clinical trials.The authors performed a fully automated quantitative MRI analysis employing atlas-based volumetry and provide sample size calculations based on data collected in 99 PSP patients assigned to placebo in these trials. Based on individual volumes of 44 brain compartments and structures at baseline and 52 weeks of follow-up, means and standard deviations of annualized percentage volume changes were used to estimate standardized effect sizes and the required sample sizes per group for future 2-armed, placebo-controlled therapeutic trials.The highest standardized effect sizes were found for midbrain, frontal lobes, and the third ventricle. Using the annualized percentage volume change of these structures to detect a 50
KW  - Aged
KW  - Clinical Trials as Topic: methods
KW  - Disease Progression
KW  - Female
KW  - Frontal Lobe: diagnostic imaging
KW  - Humans
KW  - Longitudinal Studies
KW  - Magnetic Resonance Imaging: methods
KW  - Male
KW  - Mesencephalon: diagnostic imaging
KW  - Middle Aged
KW  - Supranuclear Palsy, Progressive: diagnostic imaging
KW  - Third Ventricle: diagnostic imaging
LB  - PUB:(DE-HGF)16
C6  - pmid:28436538
C2  - pmc:PMC5808453
DO  - DOI:10.1002/mds.26973
UR  - https://pub.dzne.de/record/139314
ER  -