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Operationalizing hippocampal volume as an enrichment biomarker for amnestic mild cognitive impairment trials: effect of algorithm, test-retest variability, and cut point on trial cost, duration, and sample size.
Yu P, Sun J, Wolz R, Stephenson D, Brewer J, Fox NC, Cole PE, Jack CR Jr, Hill DL, Schwarz AJ; Coalition Against Major Diseases and the Alzheimer's Disease Neuroimaging Initiative. Yu P, et al. Among authors: stephenson d. Neurobiol Aging. 2014 Apr;35(4):808-18. doi: 10.1016/j.neurobiolaging.2013.09.039. Epub 2013 Oct 3. Neurobiol Aging. 2014. PMID: 24211008 Free PMC article.
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D. Hill DLG, et al. Among authors: stephenson d. Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003. Alzheimers Dement. 2014. PMID: 24985687
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. Stephenson D, et al. J Parkinsons Dis. 2019;9(3):553-563. doi: 10.3233/JPD-191648. J Parkinsons Dis. 2019. PMID: 31306141 Free PMC article.
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D, Somer E, Gallagher J, Dexter DT, Roach A, Stephenson D; Critical Path for Parkinson's (CPP) Consortium; Parkinson's Progression Markers Initiative (PPMI). Romero K, et al. Among authors: stephenson d. Clin Transl Sci. 2019 May;12(3):240-246. doi: 10.1111/cts.12619. Epub 2019 Mar 18. Clin Transl Sci. 2019. PMID: 30706986 Free PMC article.
Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases.
Stephenson D, Aviles E, Bain LJ, Brumfield M, Carrillo M, Comery TA, Compton C, Corrigan B, Gordon MF, Jack CR Jr, Katz R, Logovinsky V, Satlin A, Marek K, Nicholas T, Polhamus D, Angersbach BS, Raghavan N, Romano G, Romero K, Shaw L, Woodcock J, Vradenburg G, Isaac M. Stephenson D, et al. Ther Innov Regul Sci. 2013 Nov;47(6):632-638. doi: 10.1177/2168479013498386. Ther Innov Regul Sci. 2013. PMID: 30235546
Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson's Disease.
Hill DL, Stephenson D, Brayanov J, Claes K, Badawy R, Sardar S, Fisher K, Lee SJ, Bannon A, Roussos G, Kangarloo T, Terebaite V, Müller MLTM, Bhatnagar R, Adams JL, Dorsey ER, Cosman J. Hill DL, et al. Among authors: stephenson d. Sensors (Basel). 2022 Mar 9;22(6):2136. doi: 10.3390/s22062136. Sensors (Basel). 2022. PMID: 35336307 Free PMC article.
Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.
Conrado DJ, Nicholas T, Tsai K, Macha S, Sinha V, Stone J, Corrigan B, Bani M, Muglia P, Watson IA, Kern VD, Sheveleva E, Marek K, Stephenson DT, Romero K; Critical Path for Parkinson's (CPP) Parkinson's Disease Modeling and Simulation Working Group. Conrado DJ, et al. Among authors: stephenson dt. Clin Transl Sci. 2018 Jan;11(1):63-70. doi: 10.1111/cts.12492. Epub 2017 Jul 27. Clin Transl Sci. 2018. PMID: 28749580 Free PMC article.
Identifying and characterising sources of variability in digital outcome measures in Parkinson's disease.
Roussos G, Herrero TR, Hill DL, Dowling AV, L T M Müller M, Evers LJW, Burton J, Derungs A, Fisher K, Kilambi KP, Mehrotra N, Bhatnagar R, Sardar S, Stephenson D, Adams JL, Ray Dorsey E, Cosman J. Roussos G, et al. Among authors: stephenson d. NPJ Digit Med. 2022 Jul 15;5(1):93. doi: 10.1038/s41746-022-00643-4. NPJ Digit Med. 2022. PMID: 35840653 Free PMC article.
Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.
Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, Yule S. Arnerić SP, et al. Among authors: stephenson d. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
550 results