Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease

Author:

Hill Derek L.G.1,Schwarz Adam J.2,Isaac Maria3,Pani Luca3,Vamvakas Spiros3,Hemmings Robert3,Carrillo Maria C.4,Yu Peng2,Sun Jia25,Beckett Laurel6,Boccardi Marina7,Brewer James8,Brumfield Martha9,Cantillon Marc10,Cole Patricia E.2,Fox Nick11,Frisoni Giovanni B.7,Jack Clifford12,Kelleher Thomas13,Luo Feng13,Novak Gerald14,Maguire Paul15,Meibach Richard16,Patterson Patricia17,Bain Lisa18,Sampaio Cristina19,Raunig David20,Soares Holly13,Suhy Joyce21,Wang Huanli6,Wolz Robin122,Stephenson Diane9

Affiliation:

1. IXICO Ltd.LondonUK

2. Eli Lilly and CompanyIndinapolisINUSA

3. European Medicines AgencyLondonUK

4. Alzheimer's AssociationChicagoILUSA

5. The University of Texas School of Public HealthHoustonTXUSA

6. University of CaliforniaDavisCAUSA

7. IRCCS FatebenefratelliBresciaItaly

8. University of CaliforniaSan DiegoCAUSA

9. Coalition Against Major DiseasesCritical Path InstituteTucsonAZUSA

10. Wellnessmanagments.comLivingstonNJUSA

11. UCL Institute of NeurologyLondonUK

12. Mayo ClinicRochesterMNUSA

13. Bristol Myers SquibbWallingfordCTUSA

14. Janssen Pharmaceutical Research and DevelopmentTitusvilleNJUSA

15. NovartisBaselSwitzerland

16. NovartisNJUSA

17. AstraZenecaWilmingtonDEUSA

18. Independent science writerElversonPAUSA

19. CHDI Foundation Inc.PrincetonNJUSA

20. ICON Medical ImagingWarringtonPAUSA

21. SYNARC Inc.NewarkCAUSA

22. Department of ComputingImperial College LondonLondonUK

Funder

Science Foundation Arizona

US Food and Drug Association

Publisher

Wiley

Subject

Psychiatry and Mental health,Cellular and Molecular Neuroscience,Geriatrics and Gerontology,Neurology (clinical),Developmental Neuroscience,Health Policy,Epidemiology

Reference73 articles.

1. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade

2. Alliance for Aging Research AD Biomarkers Work Group: structural MRI

3. A computational neurodegenerative disease progression score: Method and results with the Alzheimer's disease neuroimaging initiative cohort

4. European Medicines Agency.Qualification of novel methodologies for drug development: guidance to applicants.Accessed November 21 2012. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004201.pdf. 2012.

5. Food and Drug Administration.Innovation or stagnation: challenges and opportunity on the critical path to new medical products.Accessed February 26 2013. Available from:http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. 2004.

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