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A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial / Sergio Álvarez Vallejo    

Público ISBD Título : A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial Tipo de documento : documento electrónico Autores : Sergio Álvarez Vallejo, Fecha de publicación : 2022 Títulos uniformes : Alzheimer's & Dementia Idioma : Inglés (eng) Palabras clave : Alzheimer’s disease  amyloid  antibody  data sharing  magnetic resonance imaging  positron emission tomography  presenilin 1  primary prevention  secondary prevention Resumen : Introduction: The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data. Methods: We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data. Results: Baseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers. Discussion: Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition. Mención de responsabilidad : Eric M. Reiman, Jeremy J. Pruzin, Silvia Rios-Romenets, Chris Brown, Margarita Giraldo, Natalia Acosta-Baena, Carlos Tobon, Nan Hu, Yinghua Chen, Valentina Ghisays, Jessica Enos, Dhruman D. Goradia, Wendy Lee, Ji Luo, Michael Malek-Ahmadi, Hillary Protas, Ronald G. Thomas, Kewei Chen, Yi Su, Connie Boker, Diego Mastroeni, Sergio Alvarez, Yakeel T. Quiroz, Jessica B. Langbaum, Kaycee M. Sink, Francisco Lopera, Pierre N. Tariot, and the API ADAD Colombia Trial Group Referencia : Alzheimers Dement. 2022 Nov 14. DOI (Digital Object Identifier) : 10.1002/alz.12843 PMID : 36373344 Derechos de uso : CC BY-NC En línea : https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12843 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6100 A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial [documento electrónico] / Sergio Álvarez Vallejo,  . - 2022. Obra : Alzheimer's & Dementia Idioma : Inglés (eng) Palabras clave : Alzheimer’s disease  amyloid  antibody  data sharing  magnetic resonance imaging  positron emission tomography  presenilin 1  primary prevention  secondary prevention Resumen : Introduction: The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data. Methods: We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data. Results: Baseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers. Discussion: Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition. Mención de responsabilidad : Eric M. Reiman, Jeremy J. Pruzin, Silvia Rios-Romenets, Chris Brown, Margarita Giraldo, Natalia Acosta-Baena, Carlos Tobon, Nan Hu, Yinghua Chen, Valentina Ghisays, Jessica Enos, Dhruman D. Goradia, Wendy Lee, Ji Luo, Michael Malek-Ahmadi, Hillary Protas, Ronald G. Thomas, Kewei Chen, Yi Su, Connie Boker, Diego Mastroeni, Sergio Alvarez, Yakeel T. Quiroz, Jessica B. Langbaum, Kaycee M. Sink, Francisco Lopera, Pierre N. Tariot, and the API ADAD Colombia Trial Group Referencia : Alzheimers Dement. 2022 Nov 14. DOI (Digital Object Identifier) : 10.1002/alz.12843 PMID : 36373344 Derechos de uso : CC BY-NC En línea : https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12843 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6100

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Documentos electrónicos

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