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024 7 _ |a pmc:PMC5808453
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024 7 _ |a 0885-3185
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024 7 _ |a 1531-8257
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024 7 _ |a altmetric:21127371
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037 _ _ |a DZNE-2020-05636
041 _ _ |a English
082 _ _ |a 610
100 1 _ |a Höglinger, Günter U
|0 P:(DE-2719)2811373
|b 0
|e First author
245 _ _ |a Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials.
260 _ _ |a New York, NY
|c 2017
|b Wiley
264 _ 1 |3 online
|2 Crossref
|b Wiley
|c 2017-04-24
264 _ 1 |3 print
|2 Crossref
|b Wiley
|c 2017-06-01
336 7 _ |a article
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336 7 _ |a Output Types/Journal article
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336 7 _ |a ARTICLE
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336 7 _ |a Journal Article
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520 _ _ |a 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% 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.
536 _ _ |a 344 - Clinical and Health Care Research (POF3-344)
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542 _ _ |i 2017-04-24
|2 Crossref
|u http://doi.wiley.com/10.1002/tdm_license_1
542 _ _ |i 2017-04-24
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|u http://onlinelibrary.wiley.com/termsAndConditions
588 _ _ |a Dataset connected to CrossRef, PubMed,
650 _ 2 |a Aged
|2 MeSH
650 _ 2 |a Clinical Trials as Topic: methods
|2 MeSH
650 _ 2 |a Disease Progression
|2 MeSH
650 _ 2 |a Female
|2 MeSH
650 _ 2 |a Frontal Lobe: diagnostic imaging
|2 MeSH
650 _ 2 |a Humans
|2 MeSH
650 _ 2 |a Longitudinal Studies
|2 MeSH
650 _ 2 |a Magnetic Resonance Imaging: methods
|2 MeSH
650 _ 2 |a Male
|2 MeSH
650 _ 2 |a Mesencephalon: diagnostic imaging
|2 MeSH
650 _ 2 |a Middle Aged
|2 MeSH
650 _ 2 |a Supranuclear Palsy, Progressive: diagnostic imaging
|2 MeSH
650 _ 2 |a Third Ventricle: diagnostic imaging
|2 MeSH
700 1 _ |a Schöpe, Jakob
|0 P:(DE-HGF)0
|b 1
700 1 _ |a Stamelou, Maria
|0 P:(DE-HGF)0
|b 2
700 1 _ |a Kassubek, Jan
|0 P:(DE-HGF)0
|b 3
700 1 _ |a Del Ser, Teodoro
|0 P:(DE-HGF)0
|b 4
700 1 _ |a Boxer, Adam L
|0 P:(DE-HGF)0
|b 5
700 1 _ |a Wagenpfeil, Stefan
|0 P:(DE-HGF)0
|b 6
700 1 _ |a Huppertz, Hans-Jürgen
|0 P:(DE-HGF)0
|b 7
700 1 _ |a Investigators, AL-108-231
|0 P:(DE-HGF)0
|b 8
700 1 _ |a Investigators, Tauros MRI
|0 P:(DE-HGF)0
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700 1 _ |a Group, Movement Disorder Society-Endorsed PSP Study
|b 10
773 1 8 |a 10.1002/mds.26973
|b : Wiley, 2017-04-24
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|t Movement Disorders
|v 32
|y 2017
|x 0885-3185
773 _ _ |a 10.1002/mds.26973
|g Vol. 32, no. 6, p. 842 - 852
|0 PERI:(DE-600)2041249-6
|n 6
|q 32:6<842 - 852
|p 842-852
|t Movement disorders
|v 32
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|x 0885-3185
856 7 _ |2 Pubmed Central
|u http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808453
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LibraryCollectionCLSMajorCLSMinorLanguageAuthor
Marc 21