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Frontotemporal degeneration: a basis for clinical trials
30 September 2003 - 31 August 2007
NATIONAL INSTITUTE ON AGING
Total Funding: $ 1,649,076
In order to test drugs in patients with tauopathies, knowledge of the natural history of the frontotemporal lobar dementias (FTLD) must be expressed in terms suitable for designing clinical trials. Without valid estimates of change over 6 or 12 months, instruments appropriate for trials and sample sizes for the trials simply cannot be determined. We are proposing a 4 year, multi-site, longitudinal study of patients with FTLD in which we will recruit subjects using standardized criteria. The specific aims of this project are 1) determine the ratio between change and variance in cognitive, behavioral and functional instruments in order to estimate power to detect treatment effects with each instrument in future clinical trials; 2) perform serial MR imaging to determine the magnitude of change and its variance in global and regional frontal or temporal brain volume in order to estimate power to detect treatment effects on brain volume in future clinical trials; 3) develop a composite FTLD-subtype-specific cognitive instrument for use in clinical trials; and 4) determine whether ApoE genotype and tau haplotype are associated with rate of progression on cognitive, behavioral, functional or imaging in FTLD. We propose to involve 3 Alzheimer Disease Centers (Mayo Rochester/Jacksonville, UCLA and Arizona) plus the University of California- San Francisco to recruit 120 patients with FTLD. We shall recruit patients with the behavioral-dysexecutive syndrome of fronto-temporal dementia, patients with semantic dementia, and patients with progressive nonfluent aphasia. Operational criteria for these 3 syndromes have been developed that will meet rigorous standards suitable for clinical trial recruitment. Subjects will be examined with cognitive, behavioral, functional assessments as well as MR imaging at baseline and 12 months. Key outcomes will include estimates of change and its variability over 1 year on MR imaging, change on cognitive tasks including the composite task, and change on functional and behavioral measures. While the study will also develop a wealth of new knowledge about the relationships between cognition, behavior and brain structure in FTLD, the essential product of this study will be the principles underlying a rationale design for trials of drugs for FTLD.
18 Resulting Publications
Po H Lu; Mario F Mendez; Grace J Lee; Alex D Leow; Hyun-Woo Lee; Jill Shapira; Elvira Jimenez; Bradley B Boeve; Richard J Caselli; Neill R Graff-Radford; et al.Dementia and geriatric cognitive disorders 2013;35(1-2):34-50.
David S Knopman; Sandra Weintraub; Vernon S PankratzAlzheimer's & dementia : the journal of the Alzheimer's Association 2011;7(3):293-9.
J L Whitwell; C R Jack; B F Boeve; J E Parisi; J E Ahlskog; D A Drubach; M L Senjem; D S Knopman; R C Petersen; D W Dickson; et al.Neurology 2010;75(21):1879-87.
Serguei V S Pakhomov; Glenn E Smith; Dustin Chacon; Yara Feliciano; Neill Graff-Radford; Richard Caselli; David S KnopmanCognitive and behavioral neurology : official journal of the Society for Behavioral and Cognitive Neurology 2010;23(3):165-77.
K Kantarci; B F Boeve; Z K Wszolek; R Rademakers; J L Whitwell; M C Baker; M L Senjem; A R Samikoglu; D S Knopman; R C Petersen; et al.Neurology 2010;75(9):771-8.
P Vemuri; H J Wiste; S D Weigand; D S Knopman; J Q Trojanowski; L M Shaw; M A Bernstein; P S Aisen; M Weiner; R C Petersen; et al.Neurology 2010;75(2):143-51.
J L Whitwell; R Avula; M L Senjem; K Kantarci; S D Weigand; A Samikoglu; H A Edmonson; P Vemuri; D S Knopman; B F Boeve; et al.Neurology 2010;74(16):1279-87.
Bei Hu; Leslie Ross; John Neuhaus; David Knopman; Joel Kramer; Bradley Boeve; Richard J Caselli; Neill Graff-Radford; Mario F Mendez; Bruce L Miller; et al.American journal of Alzheimer's disease and other dementias 2010;25(2):128-33.
Jennifer Molano; Bradley Boeve; Tanis Ferman; Glenn Smith; Joseph Parisi; Dennis Dickson; David Knopman; Neill Graff-Radford; Yonas Geda; John Lucas; et al.Brain : a journal of neurology 2010;133(Pt 2):540-56.
K A Josephs; J L Whitwell; D S Knopman; B F Boeve; P Vemuri; M L Senjem; J E Parisi; R J Ivnik; D W Dickson; R C Petersen; et al.Neurology 2009;73(18):1443-50.
S R Lesage; T H Mosley; T Y Wong; M Szklo; D Knopman; D J Catellier; S R Cole; R Klein; J Coresh; L H Coker; et al.Neurology 2009;73(11):862-8.
D S Knopman; C R Jack; J H Kramer; B F Boeve; R J Caselli; N R Graff-Radford; M F Mendez; B L Miller; N D MercaldoNeurology 2009;72(21):1843-9.
David S Knopman; Joel H Kramer; Bradley F Boeve; Richard J Caselli; Neill R Graff-Radford; Mario F Mendez; Bruce L Miller; Nathaniel MercaldoBrain : a journal of neurology 2008;131(Pt 11):2957-68.
B F Boeve; M H Silber; C B Saper; T J Ferman; D W Dickson; J E Parisi; E E Benarroch; J E Ahlskog; G E Smith; R C Caselli; et al.Brain : a journal of neurology 2007;130(Pt 11):2770-88.
David S Knopman; Bradley S Boeve; Richard J Caselli; Neill R Graff-Radford; Joel H Kramer; Mario F Mendez; Bruce L MillerAlzheimer disease and associated disorders 2007;21(4):S58-63.
Jennifer Gass; Ashley Cannon; Ian R Mackenzie; Bradley Boeve; Matt Baker; Jennifer Adamson; Richard Crook; Stacey Melquist; Karen Kuntz; Ron Petersen; et al.Human molecular genetics 2006;15(20):2988-3001.
K A Josephs; R C Petersen; D S Knopman; B F Boeve; J L Whitwell; J R Duffy; J E Parisi; D W DicksonNeurology 2006;66(1):41-8.
David S Knopman; Bradley F Boeve; Joseph E Parisi; Dennis W Dickson; Glenn E Smith; Robert J Ivnik; Keith A Josephs; Ronald C PetersenAnnals of neurology 2005;57(4):480-8.
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FOGARTY INTERNATIONAL CENTER
Total Funding: $ 70,352
Hutton, Michael L
1 September 2006 - 31 August 2008
NATIONAL INSTITUTE ON AGING
Total Funding: $ 193,800
Dekosky, Steven T
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NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE
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André DelacourteJournal of Alzheimer's disease : JAD 2006;9(3 Suppl):187-94.
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Ozioma C Okonkwo; Michael L Alosco; H Randall Griffith; Michelle M Mielke; Leslie M Shaw; John Q Trojanowski; Geoffrey Tremont;Archives of neurology 2010;67(6):688-96.
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