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387 results

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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: isaac m. Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003. Alzheimers Dement. 2014. PMID: 24985687
The future is now: model-based clinical trial design for Alzheimer's disease.
Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B; Alzheimer's Disease Neuroimaging Initiative; Coalition Against Major Diseases. Romero K, et al. Among authors: isaac m. Clin Pharmacol Ther. 2015 Mar;97(3):210-4. doi: 10.1002/cpt.16. Epub 2014 Dec 27. Clin Pharmacol Ther. 2015. PMID: 25669145 Free PMC article.
Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.
Isaac M, Vamvakas S, Abadie E, Jonsson B, Gispen C, Pani L. Isaac M, et al. Eur Neuropsychopharmacol. 2011 Nov;21(11):781-8. doi: 10.1016/j.euroneuro.2011.08.003. Epub 2011 Sep 7. Eur Neuropsychopharmacol. 2011. PMID: 21903360
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. Among authors: isaac m. Ther Innov Regul Sci. 2013 Nov;47(6):632-638. doi: 10.1177/2168479013498386. Ther Innov Regul Sci. 2013. PMID: 30235546
Multiple comorbid neuropathologies in the setting of Alzheimer's disease neuropathology and implications for drug development.
Rabinovici GD, Carrillo MC, Forman M, DeSanti S, Miller DS, Kozauer N, Petersen RC, Randolph C, Knopman DS, Smith EE, Isaac M, Mattsson N, Bain LJ, Hendrix JA, Sims JR. Rabinovici GD, et al. Among authors: isaac m. Alzheimers Dement (N Y). 2016 Sep 20;3(1):83-91. doi: 10.1016/j.trci.2016.09.002. eCollection 2017 Jan. Alzheimers Dement (N Y). 2016. PMID: 29067320 Free PMC article. Review.
Swings and Roundabouts in CNS Drug Biomarkers.
Isaac MB, Vamvakas S. Isaac MB, et al. J Prev Alzheimers Dis. 2017;4(3):134-135. doi: 10.14283/jpad.2017.18. J Prev Alzheimers Dis. 2017. PMID: 29182702 No abstract available.
Diagnostic biomarkers for Alzheimer's disease: a regulatory view.
Isaac MT, Vamvakas S, Isaac MB. Isaac MT, et al. Among authors: isaac mb. Lancet Neurol. 2017 Aug;16(8):580-581. doi: 10.1016/S1474-4422(17)30223-5. Epub 2017 Jul 11. Lancet Neurol. 2017. PMID: 28721916 No abstract available.
387 results