Search Results - "DELMAR, Paul"

A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer’s disease by Salloway, Stephen, Farlow, Martin, McDade, Eric, Clifford, David B., Wang, Guoqiao, Llibre-Guerra, Jorge J., Hitchcock, Janice M., Mills, Susan L., Santacruz, Anna M., Aschenbrenner, Andrew J., Hassenstab, Jason, Benzinger, Tammie L. S., Gordon, Brian A., Fagan, Anne M., Coalier, Kelley A., Cruchaga, Carlos, Goate, Alison A., Perrin, Richard J., Xiong, Chengjie, Li, Yan, Morris, John C., Snider, B. Joy, Mummery, Catherine, Surti, G. Mustafa, Hannequin, Didier, Wallon, David, Berman, Sarah B., Lah, James J., Jimenez-Velazquez, Ivonne Z., Roberson, Erik D., van Dyck, Christopher H., Honig, Lawrence S., Sánchez-Valle, Raquel, Brooks, William S., Gauthier, Serge, Galasko, Douglas R., Masters, Colin L., Brosch, Jared R., Hsiung, Ging-Yuek Robin, Jayadev, Suman, Formaglio, Maité, Masellis, Mario, Clarnette, Roger, Pariente, Jérémie, Dubois, Bruno, Pasquier, Florence, Jack, Clifford R., Koeppe, Robert, Snyder, Peter J., Aisen, Paul S., Thomas, Ronald G., Berry, Scott M., Wendelberger, Barbara A., Andersen, Scott W., Holdridge, Karen C., Mintun, Mark A., Yaari, Roy, Sims, John R., Baudler, Monika, Delmar, Paul, Doody, Rachelle S., Fontoura, Paulo, Giacobino, Caroline, Kerchner, Geoffrey A., Bateman, Randall J.

“…Dominantly inherited Alzheimer’s disease (DIAD) causes predictable biological changes decades before the onset of clinical symptoms, enabling testing of…”
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A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease by Ostrowitzki, Susanne, Lasser, Robert A, Dorflinger, Ernest, Scheltens, Philip, Barkhof, Frederik, Nikolcheva, Tania, Ashford, Elizabeth, Retout, Sylvie, Hofmann, Carsten, Delmar, Paul, Klein, Gregory, Andjelkovic, Mirjana, Dubois, Bruno, Boada, Mercè, Blennow, Kaj, Santarelli, Luca, Fontoura, Paulo

“…Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the…”
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Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis by Klein, Gregory, Delmar, Paul, Voyle, Nicola, Rehal, Sunita, Hofmann, Carsten, Abi-Saab, Danielle, Andjelkovic, Mirjana, Ristic, Smiljana, Wang, Guoqiao, Bateman, Randall, Kerchner, Geoffrey A, Baudler, Monika, Fontoura, Paulo, Doody, Rachelle

“…We previously investigated low doses (105 or 225 mg) of gantenerumab, a fully human monoclonal antibody that binds and removes aggregated amyloid-β by Fc…”
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Two Phase 3 Trials of Gantenerumab in Early Alzheimer’s Disease by Bateman, Randall J., Smith, Janice, Donohue, Michael C., Delmar, Paul, Abbas, Rachid, Salloway, Stephen, Wojtowicz, Jakub, Blennow, Kaj, Bittner, Tobias, Black, Sandra E., Klein, Gregory, Boada, Mercè, Grimmer, Timo, Tamaoka, Akira, Perry, Richard J., Turner, R. Scott, Watson, David, Woodward, Michael, Thanasopoulou, Angeliki, Lane, Christopher, Baudler, Monika, Fox, Nick C., Cummings, Jeffrey L., Fontoura, Paulo, Doody, Rachelle S.

“…In two randomized trials, the use of gantenerumab (an anti-Aβ monoclonal antibody) did not lead to slower clinical decline than placebo over 116 weeks among…”
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Bevacizumab in Combination With Chemotherapy As First-Line Therapy in Advanced Gastric Cancer: A Biomarker Evaluation From the AVAGAST Randomized Phase III Trial by VAN CUTSEM, Eric, DE HAAS, S. Anne, SHAH, Manish A, KANG, Yoon-Koo, OHTSU, Atsushi, TEBBUTT, Niall C, JIAN MING XU, WEI PENG YONG, LANGER, Bernd, DELMAR, Paul, SCHERER, Stefan J

“…The AVAGAST study showed that adding bevacizumab to chemotherapy in patients with advanced gastric cancer improves progression-free survival and tumor response…”
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A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL by Dimier, Natalie, Delmar, Paul, Ward, Carol, Morariu-Zamfir, Rodica, Fingerle-Rowson, Günter, Bahlo, Jasmin, Fischer, Kirsten, Eichhorst, Barbara, Goede, Valentin, van Dongen, Jacques J.M., Ritgen, Matthias, Böttcher, Sebastian, Langerak, Anton W., Kneba, Michael, Hallek, Michael

“…Our objective was to evaluate minimal residual disease (MRD) at the end of induction treatment with chemoimmunotherapy as a surrogate end point for…”
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A novel cognitive disease progression model for clinical trials in autosomal‐dominant Alzheimer's disease by Wang, Guoqiao, Berry, Scott, Xiong, Chengjie, Hassenstab, Jason, Quintana, Melanie, McDade, Eric M., Delmar, Paul, Vestrucci, Matteo, Sethuraman, Gopalan, Bateman, Randall J.

“…Clinical trial outcomes for Alzheimer's disease are typically analyzed by using the mixed model for repeated measures (MMRM) or similar models that compare an…”
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VEGF pathway genetic variants as biomarkers of treatment outcome with bevacizumab: an analysis of data from the AViTA and AVOREN randomised trials by Lambrechts, Diether, Prof, Claes, Bart, MSc, Delmar, Paul, PhD, Reumers, Joke, PhD, Mazzone, Massimiliano, Prof, Yesilyurt, Betül T, MSc, Devlieger, Roland, Prof, Verslype, Chris, Prof, Tejpar, Sabine, Prof, Wildiers, Hans, Prof, de Haas, Sanne, PhD, Carmeliet, Peter, Prof, Scherer, Stefan J, MD, Van Cutsem, Eric, Prof

“…Summary Background No biomarkers that could guide patient selection for treatment with the anti-VEGF monoclonal antibody bevacizumab have been identified. We…”
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In silico exploration of amyloid‐related imaging abnormalities in the gantenerumab open‐label extension trials using a semi‐mechanistic model by Aldea, Roxana, Grimm, Hans Peter, Gieschke, Ronald, Hofmann, Carsten, Lott, Dominik, Bullain, Szofia, Delmar, Paul, Klein, Gregory, Lyons, Marco, Piazza, Fabrizio, Carare, Roxana O., Mazer, Norman A.

“…Introduction Amyloid‐related imaging abnormalities with edema/effusion (ARIA‐E) are commonly observed with anti‐amyloid therapies in Alzheimer's disease. We…”
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Proportional constrained longitudinal data analysis models for clinical trials in sporadic Alzheimer's disease by Wang, Guoqiao, Liu, Lei, Li, Yan, Aschenbrenner, Andrew J., Bateman, Randall J., Delmar, Paul, Schneider, Lon S., Kennedy, Richard E., Cutter, Gary R., Xiong, Chengjie

“…Introduction Clinical trials for sporadic Alzheimer's disease generally use mixed models for repeated measures (MMRM) or, to a lesser degree, constrained…”
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Overview of dominantly inherited AD and top‐line DIAN‐TU results of solanezumab and gantenerumab by Bateman, Randall J, Aschenbrenner, Andrew J., Benzinger, Tammie L.S., Clifford, David, Coalier, Kelley, Cruchaga, Carlos, Fagan, Anne M., Farlow, Martin R., Goate, Alison M., Gordon, Brian A., Hassenstab, Jason, Jack, Clifford R., Koeppe, Robert A., McDade, Eric, Mills, Susan, Morris, John C., Salloway, Stephen P., Santacruz, Anna, Snyder, Peter J., Wang, Guoqiao, Xiong, Chengjie, Snider, B. Joy, Mummery, Catherine J., Surti, Ghulam M., Hannequin, Didier, Wallon, David, Berman, Sarah, Lah, James J., Jiménez‐Velazquez, Ivonne Z., Roberson, Erik D., Dyck, Christopher H., Honig, Lawrence S., Sanchez‐Valle, Raquel, Brooks, William S., Gauthier, Serge, Masters, Colin L., Galasko, Doug R., Brosch, Jared R., Hsiung, Ging‐Yuek Robin, Jayadev, Suman, Formaglio, Maïté, Masellis, Mario, Clarnette, Roger, Pariente, Jeremie, Dubois, Bruno, Pasquier, Florence, Andersen, Scott W., Holdridge, Karen C., Mintun, Mark A., Sims, John R., Yaari, Roy, Baudler, Monika, Delmar, Paul, Doody, Rachelle, Fontoura, Paulo, Kerchner, Geoffrey A.

“…Background Alzheimer’s disease (AD) prevention trials aim to intervene prior to significant neuronal loss, brain damage, and symptom onset to delay or slow…”
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Innovative methods for the identification of predictive biomarker signatures in oncology: Application to bevacizumab by Delmar, Paul, Irl, Cornelia, Tian, Lu

“…Abstract Current methods for subgroup analyses of data collected from randomized clinical trials (RCTs) may lead to false-positives from multiple testing, lack…”
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The Transcriptional Coactivator Peroxisome Proliferator–Activated Receptor (PPAR)γ Coactivator-1α and the Nuclear Receptor PPARα Control the Expression of Glycerol Kinase and Metabolism Genes Independently of PPARγ Activation in Human White Adipocytes by Mazzucotelli, Anne, Viguerie, Nathalie, Tiraby, Claire, Annicotte, Jean-Sébastien, Mairal, Aline, Klimcakova, Eva, Lepin, Emmanuelle, Delmar, Paul, Dejean, Sébastien, Tavernier, Geneviève, Lefort, Corinne, Hidalgo, Juan, Pineau, Thierry, Fajas, Lluis, Clément, Karine, Langin, Dominique

“…The Transcriptional Coactivator Peroxisome Proliferator–Activated Receptor (PPAR)γ Coactivator-1α and the Nuclear Receptor PPARα Control the Expression of…”
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Correction to: A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease by Ostrowitzki, Susanne, Lasser, Robert A, Dorflinger, Ernest, Scheltens, Philip, Barkhof, Frederik, Nikolcheva, Tania, Ashford, Elizabeth, Retout, Sylvie, Hofmann, Carsten, Delmar, Paul, Klein, Gregory, Andjelkovic, Mirjana, Dubois, Bruno, Boada, Mercè, Blennow, Kaj, Santarelli, Luca, Fontoura, Paulo

“…Following publication of the original article [1], the author reported errors in the formatting of the table. The details of the errors are as follows…”
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An industry statistician's perspective on PHC drug development by Fridlyand, Jane, Yeh, Ru-Fang, Mackey, Howard, Bengtsson, Thomas, Delmar, Paul, Spaniolo, Greg, Lieberman, Grazyna

“…Abstract In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are…”
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Preclinical biomarkers for a cyclin-dependent kinase inhibitor translate to candidate pharmacodynamic biomarkers in phase I patients by Berkofsky-Fessler, Windy, Nguyen, Tri Q., Delmar, Paul, Molnos, Juliette, Kanwal, Charu, DePinto, Wanda, Rosinski, James, McLoughlin, Patricia, Ritland, Steve, DeMario, Mark, Tobon, Krishna, Reidhaar-Olson, John F., Rueger, Ruediger, Hilton, Holly

“…A genomics-based approach to identify pharmacodynamic biomarkers was used for a cyclin-dependent kinase inhibitory drug. R547 is a potent cyclin-dependent…”
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Evaluating Digital Twins for Alzheimer’s Disease using Data from a Completed Phase 2 Clinical Trial by Walsh, Jonathan R., Roumpanis, Spyros, Bertolini, Daniele, Delmar, Paul

“…Background Complex Alzheimer’s Disease (AD) clinical trials that require a large number of subjects leads to long trial timelines and significant costs. Our…”
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Real-world anaplastic lymphoma kinase (ALK) rearrangement testing patterns, treatment sequences, and survival of ALK inhibitor-treated patients by Davies, Jessica, Martinec, Michael, Coudert, Mathieu, Delmar, Paul, Crane, Gracy

“…Background: The anaplastic lymphoma kinase (ALK) treatment landscape is crowded following recent ALK inhibitor approvals, and updated information on real-world…”
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Associations of patient‐specific resting state variability with CSF and clinical biomarkers: Data from Alzheimer’s disease clinical trials by Gobbi, Susanna, Scelsi, Marzia A., Delmar, Paul, Bittner, Tobias, Klein, Gregory, Magon, Stefano

“…Background Changes of brain functional connectivity assessed using MRI in patients with Alzheimer’s disease (AD) have been previously reported. However,…”
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Selecting appropriate meaningful change thresholds for trials of early (prodromal‐to‐mild) AD: A caregiver‐rated, anchor‐based analysis based on the Tauriel Study by Lansdall, Claire J, Teng, Edmond, McDougall, Fiona, Delmar, Paul, Smith, Janice, Manser, Paul T

“…Background Clinically meaningful change thresholds for assessments used in Alzheimer’s disease (AD) trials, including the Clinical Dementia Rating Scale – Sum…”
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