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6. Value-Generating Exploratory Trials in Neurodegenerative Dementias

Author

Friedman, Lauren G, McKeehan, Nicholas, Hara, Yuko, Cummings, Jeffrey L, Matthews, Dawn C, Zhu, Jian, Mohs, Richard C, Wang, Deli, Hendrix, Suzanne B, Quintana, Melanie, Schneider, Lon S, Grundman, Michael, Dickson, Samuel P, Feldman, Howard H, Jaeger, Judith, Finger, Elizabeth C, Ryan, J Michael, Niehoff, Debra, Dickinson, Susan L-J, Markowitz, Jessica T, Owen, Meriel, Travaglia, Alessio, and Fillit, Howard M

Subjects
Dementia, Clinical Research, Clinical Trials and Supportive Activities, Acquired Cognitive Impairment, Aging, Alzheimer's Disease, Neurosciences, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Brain Disorders, Patient Safety, Neurodegenerative, 8.4 Research design and methodologies (health services), Health and social care services research, Neurological, Alzheimer Disease, Clinical Trials as Topic, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Drug Development, Frontotemporal Dementia, Humans, Neurodegenerative Diseases, Outcome Assessment, Health Care, Proof of Concept Study, Research Design, Treatment Failure, Treatment Outcome, Clinical Sciences, Cognitive Sciences, Neurology & Neurosurgery
Abstract

Drug development for Alzheimer disease and other neurodegenerative dementias, including frontotemporal dementia, has experienced a long history of phase 2 and phase 3 clinical trials that failed to show efficacy of investigational drugs. Despite differences in clinical and behavioral characteristics, these disorders have shared pathologies and face common challenges in designing early-phase trials that are predictive of late-stage success. Here, we discuss exploratory clinical trials in neurodegenerative dementias. These are generally phase 1b or phase 2a trials that are designed to assess pharmacologic effects and rely on biomarker outcomes, with shorter treatment durations and fewer patients than traditional phase 2 studies. Exploratory trials can establish go/no-go decision points, support proof of concept and dose selection, and terminate drugs that fail to show target engagement with suitable exposure and acceptable safety profiles. Early failure saves valuable resources including opportunity costs. This is especially important for programs in academia and small biotechnology companies but may be applied to high-risk projects in large pharmaceutical companies to achieve proof of concept more rapidly at lower costs than traditional approaches. Exploratory studies in a staged clinical development program may provide promising data to warrant the substantial resources needed to advance compounds through late-stage development. To optimize the design and application of exploratory trials, the Alzheimer's Drug Discovery Foundation and the Association for Frontotemporal Degeneration convened an advisory panel to provide recommendations on outcome measures and statistical considerations for these types of studies and study designs that can improve efficiency in clinical development.

Published
2021

18. Validation and test–retest repeatability performance of parametric methods for [11C]UCB-J PET

Author

Tuncel, Hayel, Boellaard, Ronald, Coomans, Emma M., Hollander-Meeuwsen, Marijke den, de Vries, Erik F. J., Glaudemans, Andor W. J. M., Feltes, Paula Kopschina, García, David Vállez, Verfaillie, Sander C. J., Wolters, Emma E., Sweeney, Steven P., Ryan, J. Michael, Ivarsson, Magnus, Lynch, Berkley A., Schober, Patrick, Scheltens, Philip, Schuit, Robert C., Windhorst, Albert D., De Deyn, Peter P., van Berckel, Bart N. M., and Golla, Sandeep S. V.

Published
2022
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19. Transformations in Social Science Research Methods during the COVID-19 Pandemic

Author

Ryan, J. Michael, Visanich, Valerie, and Brändle, Gaspar

Subjects
Social Science, Sociology, Research Methods, Methodology, COVID-19, Pandemic, Qualitative Research, Quantitative Research, Online Research, thema EDItEUR::J Society and Social Sciences::JB Society and culture: general, thema EDItEUR::J Society and Social Sciences::JH Sociology and anthropology::JHB Sociology, thema EDItEUR::G Reference, Information and Interdisciplinary subjects::GP Research and information: general::GPS Research methods: general
Abstract

This volume explores how researchers made innovative use of online technologies to innovate, define, and transform research methodologies in light of the varying impacts of the COVID-19 pandemic, especially those related to the ability to conduct qualitative research. The onset of the COVID-19 pandemic resulted in a radical shift in the way that people all over the world were/have been able to live, work, study, and conduct their daily lives. Academics and other professionals who routinely engage in research were no exception. The sudden, continued, and uneven need for health mandates calling for physical distancing added a particular layer of complexity for those who used research methods that typically required face-to-face interactions. Continued technological developments associated with the Internet had already given rise to ongoing debates on innovative methodological thinking and practices. The COVID-19 pandemic has further accentuated how indispensable the internet has become for the private and public lives of those with access to it, including for their employment, education, leisure, and social interactions. For those fortunate enough to have access to them, communication software such as Zoom and Google Meet have also become indispensable digital resources for researchers seeking to continue conducting research during lockdowns and quarantines, and beyond. More than ever, researchers are finding it useful, even necessary, to equip themselves with online research tools in order to be able to continue conducting their fieldwork. Drawing on research and case studies from around the world, this volume serves as a guidebook for those interested in attuning their own research methods to a world still struggling to grapple with the impacts of the COVID-19 pandemic.

Published
2024
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35. In vivo tau pathology is associated with synaptic loss and altered synaptic function

Author

Coomans, Emma M., Schoonhoven, Deborah N., Tuncel, Hayel, Verfaillie, Sander C. J., Wolters, Emma E., Boellaard, Ronald, Ossenkoppele, Rik, den Braber, Anouk, Scheper, Wiep, Schober, Patrick, Sweeney, Steven P., Ryan, J. Michael, Schuit, Robert C., Windhorst, Albert D., Barkhof, Frederik, Scheltens, Philip, Golla, Sandeep S. V., Hillebrand, Arjan, Gouw, Alida A., and van Berckel, Bart N. M.

Published
2021
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36. The Alzheimer's Prevention Initiative Generation Program: Study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer's disease

Author

Lopez Lopez, Cristina, Tariot, Pierre N., Caputo, Angelika, Langbaum, Jessica B., Liu, Fonda, Riviere, Marie-Emmanuelle, Langlois, Carolyn, Rouzade-Dominguez, Marie-Laure, Zalesak, Martin, Hendrix, Suzanne, Thomas, Ronald G., Viglietta, Vissia, Lenz, Rob, Ryan, J. Michael, Graf, Ana, and Reiman, Eric M.

Published
2019
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45. Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease

Author

Caputo, Angelika, primary, Racine, Amy, additional, Paule, Ines, additional, Tariot, Pierre N., additional, Langbaum, Jessica B., additional, Coello, Neva, additional, Riviere, Marie-Emmanuelle, additional, Ryan, J. Michael, additional, Lopez, Cristina Lopez, additional, and Graf, Ana, additional

Published
2022
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46. Additional file 1 of Rationale for the selection of dual primary endpoints in prevention studies of cognitively unimpaired individuals at genetic risk for developing symptoms of Alzheimer’s disease

Author

Caputo, Angelika, Racine, Amy, Paule, Ines, Tariot, Pierre N., Langbaum, Jessica B., Coello, Neva, Riviere, Marie-Emmanuelle, Ryan, J. Michael, Lopez, Cristina Lopez, and Graf, Ana

Abstract

Additional file 1: Supplemental material. Fig. S1. Cognitive composites over time by genotype: individual time profiles and LOESS estimates for progressors to dementia. Fig. S2. Cross validation of TTE model structure. Fig. S3. Model diagnostic of the APCC model for non-progressors (VPC).

Published
2023
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