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000139314 041__ $$aEnglish
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000139314 1001_ $$0P:(DE-2719)2811373$$aHöglinger, Günter U$$b0$$eFirst author
000139314 245__ $$aLongitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials.
000139314 260__ $$aNew York, NY$$bWiley$$c2017
000139314 264_1 $$2Crossref$$3online$$bWiley$$c2017-04-24
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000139314 520__ $$aTwo 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% change in the 1-year progression (80% power, significance level 5%) required lower numbers of patients per group (third ventricle, n = 32; midbrain, n = 37; frontal lobe, n = 43) than the best clinical scale (PSP rating scale total score, n = 58). A combination of volume changes in these 3 structures reduced the number of required patients to only 20 and correlated best with the progression in the clinical scales.We propose the 1-year change in the volumes of third ventricle, midbrain, and frontal lobe as combined imaging read-out for clinical trials in PSP that require the least number of patients for detecting efficacy to reduce brain atrophy. © 2017 International Parkinson and Movement Disorder Society.
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000139314 650_2 $$2MeSH$$aAged
000139314 650_2 $$2MeSH$$aClinical Trials as Topic: methods
000139314 650_2 $$2MeSH$$aDisease Progression
000139314 650_2 $$2MeSH$$aFemale
000139314 650_2 $$2MeSH$$aFrontal Lobe: diagnostic imaging
000139314 650_2 $$2MeSH$$aHumans
000139314 650_2 $$2MeSH$$aLongitudinal Studies
000139314 650_2 $$2MeSH$$aMagnetic Resonance Imaging: methods
000139314 650_2 $$2MeSH$$aMale
000139314 650_2 $$2MeSH$$aMesencephalon: diagnostic imaging
000139314 650_2 $$2MeSH$$aMiddle Aged
000139314 650_2 $$2MeSH$$aSupranuclear Palsy, Progressive: diagnostic imaging
000139314 650_2 $$2MeSH$$aThird Ventricle: diagnostic imaging
000139314 7001_ $$0P:(DE-HGF)0$$aSchöpe, Jakob$$b1
000139314 7001_ $$0P:(DE-HGF)0$$aStamelou, Maria$$b2
000139314 7001_ $$0P:(DE-HGF)0$$aKassubek, Jan$$b3
000139314 7001_ $$0P:(DE-HGF)0$$aDel Ser, Teodoro$$b4
000139314 7001_ $$0P:(DE-HGF)0$$aBoxer, Adam L$$b5
000139314 7001_ $$0P:(DE-HGF)0$$aWagenpfeil, Stefan$$b6
000139314 7001_ $$0P:(DE-HGF)0$$aHuppertz, Hans-Jürgen$$b7
000139314 7001_ $$0P:(DE-HGF)0$$aInvestigators, AL-108-231$$b8
000139314 7001_ $$0P:(DE-HGF)0$$aInvestigators, Tauros MRI$$b9
000139314 7001_ $$aGroup, Movement Disorder Society-Endorsed PSP Study$$b10
000139314 77318 $$2Crossref$$3journal-article$$a10.1002/mds.26973$$b : Wiley, 2017-04-24$$n6$$p842-852$$tMovement Disorders$$v32$$x0885-3185$$y2017
000139314 773__ $$0PERI:(DE-600)2041249-6$$a10.1002/mds.26973$$gVol. 32, no. 6, p. 842 - 852$$n6$$p842-852$$q32:6<842 - 852$$tMovement disorders$$v32$$x0885-3185$$y2017
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