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1. Recruitment across two decades of NIH-funded Alzheimer's disease clinical trials

Author

Ritchie, Marina, Gillen, Daniel L, and Grill, Joshua D

Subjects
Aging, Prevention, Clinical Trials and Supportive Activities, Neurosciences, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Neurodegenerative, Alzheimer's disease, Alzheimer's Disease, Medical and Health Sciences, Brain Disorders, Clinical trials, Alzheimer Disease, Clinical Research, Acquired Cognitive Impairment, Humans, Accrual, Dementia, Recruitment, Alzheimer’s disease, Retrospective Studies
Abstract

BackgroundTimely accrual of a representative sample is a key factor in whether Alzheimer's disease (AD) clinical trials successfully answer the scientific questions under study. Studies in other fields have observed that, over time, recruitment to trials has become increasingly reliant on larger numbers of sites, with declines in the average per-site recruitment rate. Here, we examined the trends in recruitment over a 20-year period of NIH-funded AD clinical trials conducted by the Alzheimer's Disease Cooperative Study (ADCS), a temporally consistent network of sites devoted to interventional research.MethodsWe performed retrospective analyses of eleven ADCS randomized clinical trials. To examine the recruitment planning, we calculated the expected number of participants to be enrolled per site for each trial. To examine the actual trial recruitment rates, we quantified the number of participants enrolled per site per month.ResultsNo effects of time were observed on recruitment planning or overall recruitment rates across trials. No trial achieved an overall recruitment rate greater than one subject per site per month. We observed the fastest recruitment rates in trials with no competition and the slowest in trials that overlapped in time. The highest recruitment rates were consistently seen early within trials and declined over the course of studies.ConclusionsTrial recruitment projections should plan for fewer than one participant randomized per site per month and consider the number of other AD trials being conducted concurrently.

Published
2023

4. Corrigendum to: More than smell: COVID-19 is associated with severe impairment of smell, taste, and chemesthesis

Author

Parma, Valentina, Ohla, Kathrin, Veldhuizen, Maria G., Niv, Masha Y., Kelly, Christine E., Bakke, Alyssa J., Cooper, Keiland W., Bouysset, Cédric, Pirastu, Nicola, Dibattista, Michele, Kaur, Rishemjit, Liuzza, Marco Tullio, Pepino, Marta Y., Schöpf, Veronika, Pereda-Loth, Veronica, Olsson, Shannon B., Gerkin, Richard C., Rohlfs Domínguez, Paloma, Albayay, Javier, Farruggia, Michael C., Bhutani, Surabhi, Fjaeldstad, Alexander W., Kumar, Ritesh, Menini, Anna, Bensafi, Moustafa, Sandell, Mari, Konstantinidis, Iordanis, Di Pizio, Antonella, Genovese, Federica, Öztürk, Lina, Thomas-Danguin, Thierry, Frasnelli, Johannes, Boesveldt, Sanne, Saatci, Özlem, Saraiva, Luis R., Lin, Cailu, Golebiowski, Jérôme, Hwang, Liang Dar, Ozdener, Mehmet Hakan, Guàrdia, Maria Dolors, Laudamiel, Christophe, Ritchie, Marina, Havlícek, Jan, Pierron, Denis, Roura, Eugeni, Navarro, Marta, Nolden, Alissa A., Lim, Juyun, Whitcroft, Katherine L., Colquitt, Lauren R., Ferdenzi, Camille, Brindha, Evelyn V., Altundag, Aytug, Macchi, Alberto, Nunez-Parra, Alexia, Patel, Zara M., Fiorucci, Sébastien, Philpott, Carl M., Smith, Barry C., Lundström, Johan N., Mucignat, Carla, Parker, Jane K., Van Den Brink, Mirjam, Schmuker, Michael, Fischmeister, Florian Ph S., Heinbockel, Thomas, Shields, Vonnie D.C., Faraji, Farhoud, Santamaría, Enrique, Fredborg, William E.A., Morini, Gabriella, Olofsson, Jonas K., Jalessi, Maryam, Karni, Noam, D'Errico, Anna, Alizadeh, Rafieh, Pellegrino, Robert, Meyer, Pablo, Huart, Caroline, Chen, Ben, Soler, Graciela M., Alwashahi, Mohammed K., Welge-Lüssen, Antje, Freiherr, Jessica, De Groot, Jasper H.B., Klein, Hadar, Okamoto, Masako, Singh, Preet Bano, Hsieh, Julien W., Abdulrahman, Olagunju, Dalton, Pamela, Yan, Carol H., Voznessenskaya, Vera V., Chen, Jingguo, Sell, Elizabeth A., Walsh-Messinger, Julie, Archer, Nicholas S., Koyama, Sachiko, Deary, Vincent, Roberts, S.C., Yanlk, Hüseyin, Albayrak, Samet, Nováková, Lenka Martinec, Croijmans, Ilja, Mazal, Patricia Portillo, Moein, Shima T., Margulis, Eitan, Mignot, Coralie, Mariño, Sajidxa, Georgiev, Dejan, Kaushik, Pavan K., Malnic, Bettina, Wang, Hong, Seyed-Allaei, Shima, Yoluk, Nur, Razzaghi-Asl, Sara, Justice, Jeb M., Restrepo, Diego, Reed, Danielle R., Hummel, Thomas, Munger, Steven D., Hayes, John E., UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/NEUR - Clinical Neuroscience, and UCL - (SLuc) Service d'oto-rhino-laryngologie

Subjects
Behavioral Neuroscience, Sensoriek en eetgedrag, Behaviour Change and Well-being, Physiology, Physiology (medical), ddc:540, Life Science, Sensory Systems, Sensory Science and Eating Behaviour, VLAG
Abstract

This is a correction notice for article bjaa041 (DOI: https:// doi.org/10.1093/chemse/bjaa041), published 20 June 2020. An incorrect version of the caption to Figure 5 was mistakenly included in the published paper. An updated version is given below. Neither the data nor the paper's conclusions were affected by this correction. The authors sincerely apologize for the error. (A) Correlations between the 3 principal components with respect to changes in 3 chemosensory modalities (i.e., taste, smell, and chemesthesis). Shades of gray indicate positive correlation, whereas shades of red indicate negative correlations. White denotes no correlation. (B) Clusters of participants identified by k-means clustering. The scatterplot shows each participant's loading on dimension 1 (degree of smell and taste loss, PC1 on x-Axis) and dimension 2 (degree of chemesthesis loss, PC2 on y-Axis). Based on the centroid of each cluster, participants in cluster 1 (blue, N = 1767; top left) are generally characterized by significant smell, taste and chemesthesis loss. Participants in cluster 2 (orange, N = 1724; bottom center) are generally characterized by ratings that reflect smell/taste loss with preserved chemesthesis. Loadings for participants in cluster 3 (green, N = 548; right side) are generally characterized by reduced smell and taste loss, and preserved chemesthesis.

Published
2021
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5. Recent Smell Loss Is the Best Predictor of COVID-19 Among Individuals With Recent Respiratory Symptoms

Author

Gerkin, Richard, Ohla, Kathrin, Veldhuizen, Maria, Joseph, Paule, Kelly, Christine, Bakke, Alyssa, Steele, Kimberley, Farruggia, Michael, Pellegrino, Robert, Pepino, Marta, Bouysset, Cédric, Soler, Graciela, Pereda-Loth, Veronica, Dibattista, Michele, Cooper, Keiland, Croijmans, Ilja, Di Pizio, Antonella, Ozdener, Mehmet Hakan, Fjaeldstad, Alexander, Lin, Cailu, Sandell, Mari, Singh, Preet, Brindha, Evelyn, Olsson, Shannon, Saraiva, Luis, Ahuja, Gaurav, Alwashahi, Mohammed, Bhutani, Surabhi, D’Errico, Anna, Fornazieri, Marco, Golebiowski, Jérôme, Dar Hwang, Liang, Öztürk, Lina, Roura, Eugeni, Spinelli, Sara, Whitcroft, Katherine, Faraji, Farhoud, Fischmeister, Florian, Heinbockel, Thomas, Hsieh, Julien, Huart, Caroline, Konstantinidis, Iordanis, Menini, Anna, Morini, Gabriella, Olofsson, Jonas, Philpott, Carl, Pierron, Denis, Shields, Vonnie, Voznessenskaya, Vera, Albayay, Javier, Altundag, Aytug, Bensafi, Moustafa, Bock, María Adelaida, Calcinoni, Orietta, Fredborg, William, Laudamiel, Christophe, Lim, Juyun, Lundström, Johan, Macchi, Alberto, Meyer, Pablo, Moein, Shima, Santamaría, Enrique, Sengupta, Debarka, Rohlfs Dominguez, Paloma, Yanik, Hüseyin, Hummel, Thomas, Hayes, John, Reed, Danielle, Niv, Masha, Munger, Steven, Parma, Valentina, Boesveldt, Sanne, de Groot, Jasper, Dinnella, Caterina, Freiherr, Jessica, Laktionova, Tatiana, Marino, Sajidxa, Monteleone, Erminio, Nunez-Parra, Alexia, Abdulrahman, Olagunju, Ritchie, Marina, Thomas-Danguin, Thierry, Walsh-Messinger, Julie, Al Abri, Rashid, Alizadeh, Rafieh, Bignon, Emmanuelle, Cantone, Elena, Paola Cecchini, Maria, Chen, Jingguo, Dolors Guàrdia, Maria, Hoover, Kara, Karni, Noam, Navarro, Marta, Nolden, Alissa, Portillo Mazal, Patricia, Rowan, Nicholas, Sarabi-Jamab, Atiye, Archer, Nicholas, Chen, Ben, Di Valerio, Elizabeth, Feeney, Emma, Frasnelli, Johannes, Hannum, Mackenzie, Hopkins, Claire, Klein, Hadar, Mignot, Coralie, Mucignat, Carla, Ning, Yuping, Ozturk, Elif, Peng, Mei, Saatci, Ozlem, Sell, Elizabeth, Yan, Carol, Alfaro, Raul, Coureaud, G., Herriman, Riley, Justice, Jeb, Kaushik, Pavan Kumar, Koyama, Sachiko, Overdevest, Jonathan, Pirastu, Nicola, Ramirez, Vicente, Roberts, S. Craig, Smith, Barry, Cao, Hongyuan, Wang, Hong, Balungwe Birindwa, Patrick, Baguma, Marius, Ozdener, Mehmet, Bock, María, Kaushik, Pavan, Pizio, Antonella, Hakan Ozdener, Mehmet, D'Errico, Anna, Hwang, Liang Dar, Group, GCCR, Cecchini, Maria, Indústries Alimentàries, Qualitat i Tecnologia Alimentària, Arizona State University [Tempe] (ASU), Forschungszentrum Jülich GmbH | Centre de recherche de Juliers, Helmholtz-Gemeinschaft = Helmholtz Association, Mersin University, National Institutes of Health [Bethesda] (NIH), AbScent, Pennsylvania State University (Penn State), Penn State System, Yale University [New Haven], University of Tennessee, University of Illinois at Urbana-Champaign [Urbana], University of Illinois System, Institut de Chimie de Nice (ICN), Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Côte d'Azur (UCA)-Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA), Buenos Aires University and GEOG (Grupo de Estudio de Olfato y Gusto), Centre d'anthropologie et de génomique de Toulouse (CAGT), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS), Università degli studi di Bari Aldo Moro (UNIBA), University of California, Utrecht University [Utrecht], Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Monell Chemical Senses Center, Regional Hospital West Jutland [Denmark], University of Helsinki, University of Oslo (UiO), Karunya Institute of Technology and Sciences, Tata Institute of Fundamental Research, Sidra Medicine [Doha, Qatar], Indraprastha Institute of Information Technology [New Delhi] (IIIT-Delhi), Sultan Qaboos University (SQU), San Diego State University (SDSU), Goethe-University Frankfurt am Main, State University of Londrina = Universidade Estadual de Londrina, Elena Cantone, University of Queensland - The Diamantina Institute, University of Queensland [Brisbane], Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), University College of London [London] (UCL), UC San Diego Health, Karl-Franzens-Universität [Graz, Autriche], Howard University College of Medicine [Washington, DC, USA], Geneva University Hospitals and Geneva University, Cliniques Universitaires Saint-Luc [Bruxelles], Aristotle University of Thessaloniki, Scuola Internazionale Superiore di Studi Avanzati / International School for Advanced Studies (SISSA / ISAS), Stockholm University, University of East Anglia [Norwich] (UEA), Towson University [Towson, MD, United States], University of Maryland System, Severtsov Institute of Ecology and Evolution RAS, University of Padova [Padova, Italy], Biruni University, Centre de recherche en neurosciences de Lyon (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospital General de Barrio Obrero [Asunción, Paraguay] (Public Hospital Barrio Obrero ), Private practice [Milan], DreamAir Llc, Oregon State University (OSU), Karolinska Institutet [Stockholm], University of Insubria, Varese, IBM Watson Research Center, IBM, Navarrabiomed-IdiSNA, University of Extremadura, Technische Universität Dresden = Dresden University of Technology (TU Dresden), The Hebrew University of Jerusalem (HUJ), University of Florida [Gainesville] (UF), Temple University [Philadelphia], Pennsylvania Commonwealth System of Higher Education (PCSHE), Wageningen University and Research [Wageningen] (WUR), Radboud university [Nijmegen], Friedrich-Alexander Universität Erlangen-Nürnberg (FAU), Universidad de Chile = University of Chile [Santiago] (UCHILE), Federal University of Technology of Akure (FUTA), University of California [Berkeley], Centre des Sciences du Goût et de l'Alimentation [Dijon] (CSGA), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université Bourgogne Franche-Comté [COMUE] (UBFC), University of Dayton, Iran University of Medical Sciences [Tehran, Iran] (IUMS), 'Federico II' University of Naples Medical School, University of Verona (UNIVR), Xi'an Jiaotong University (Xjtu), Institute of Agrifood Research and Technology (IRTA), University of Alaska [Fairbanks] (UAF), The Hebrew University Medical Center, University of Massachusetts System (UMASS), Instituto Universitario del Hospital Italiano [Buenos Aires, Argentina], Johns Hopkins University School of Medicine [Baltimore], Institute for Research in Fundamental Sciences [Tehran] (IPM), CSIRO Agriculture and Food (CSIRO), The First Affiliated Hospital of Guangzhou Medical University (GMU), University College Dublin [Dublin] (UCD), Université du Québec à Trois-Rivières (UQTR), Guy’s and St. Thomas’ Hospitals, University of Padova, Kilis Yedi Aralik University, University of Otago [Dunedin, Nouvelle-Zélande], Sancaktepe Education and Research Hospital, University of Pennsylvania [Philadelphia], University of California San Diego Health, Indiana University [Bloomington], Indiana University System, Columbia University Medical Center (CUMC), Columbia University [New York], University of Edinburgh, University of California [Merced], University of Stirling, University of London [London], Florida State University [Tallahassee] (FSU), Université catholique de Bukavu, University of Southern Queensland (USQ), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Côte d'Azur (UCA), Technical University of Munich (TUM), University of Graz, Publica, Gerkin, Richard C, Ohla, Kathrin, Veldhuizen, Maria G, Joseph, Paule V, Kelly, Christine E, Bakke, Alyssa J, Steele, Kimberley E, Farruggia, Michael C, Pellegrino, Robert, Pepino, Marta Y, Bouysset, Cédric, Soler, Graciela M, Pereda-Loth, Veronica, Dibattista, Michele, Cooper, Keiland W, Croijmans, Ilja, Di Pizio, Antonella, Ozdener, M Hakan, Fjaeldstad, Alexander W, Lin, Cailu, Sandell, Mari A, Singh, Preet B, Brindha, V Evelyn, Olsson, Shannon B, Saraiva, Luis R, Ahuja, Gaurav, Alwashahi, Mohammed K, Bhutani, Surabhi, D'Errico, Anna, Fornazieri, Marco A, Golebiowski, Jérôme, Hwang, Liang-Dar, Öztürk, Lina, Roura, Eugeni, Spinelli, Sara, Whitcroft, Katherine L, Faraji, Farhoud, Fischmeister, Florian PhS, Heinbockel, Thoma, Hsieh, Julien W, Huart, Caroline, Konstantinidis, Iordani, Menini, Anna, Morini, Gabriella, Olofsson, Jonas K, Philpott, Carl M, Pierron, Deni, Shields, Vonnie D C, Voznessenskaya, Vera V, Albayay, Javier, Altundag, Aytug, Bensafi, Moustafa, Bock, María Adelaida, Calcinoni, Orietta, Fredborg, William, Laudamiel, Christophe, Lim, Juyun, Lundström, Johan N, Macchi, Alberto, Meyer, Pablo, Moein, Shima T, Santamaría, Enrique, Sengupta, Debarka, Dominguez, Paloma Rohlf, Yanik, Hüseyin, Hummel, Thoma, Hayes, John E, Reed, Danielle R, Niv, Masha Y, Munger, Steven D, Parma, Valentina, Tıp Fakültesi, UCL - SSS/IONS/NEUR - Clinical Neuroscience, and UCL - (SLuc) Service d'oto-rhino-laryngologie

Subjects
Male, Multivariate statistics, Physiology, Cross-sectional study, [SDV]Life Sciences [q-bio], coronavirus, Logistic regression, Settore BIO/09 - Fisiologia, Behavioral Neuroscience, 0302 clinical medicine, Hyposmia, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine, 030223 otorhinolaryngology, Sensory Science and Eating Behaviour, Chemosensory, hyposmia, Middle Aged, Prognosis, olfactory, Sensory Systems, Smell, chemosensory, ddc:540, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Female, HEALTH, medicine.symptom, Adult, medicine.medical_specialty, Anosmia, Coronavirus, Olfactory, Prediction, COVID-19, Cross-Sectional Studies, Humans, SARS-CoV-2, Self Report, 663/664, Visual analogue scale, Odds, 03 medical and health sciences, Physiology (medical), Internal medicine, QUALITY, [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs, COVID-19 symptoms, Behaviour Change and Well-being, IDENTIFICATION, business.industry, Univariate, prediction, Sensoriek en eetgedrag, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, anosmia, Smell impairment
Abstract

Contains fulltext : 228204.pdf (Publisher’s version ) (Closed access) In a preregistered, cross-sectional study we investigated whether olfactory loss is a reliable predictor of COVID-19 using a crowdsourced questionnaire in 23 languages to assess symptoms in individuals self-reporting recent respiratory illness. We quantified changes in chemosensory abilities during the course of the respiratory illness using 0-100 visual analog scales (VAS) for participants reporting a positive (C19+; n=4148) or negative (C19-; n=546) COVID-19 laboratory test outcome. Logistic regression models identified univariate and multivariate predictors of COVID-19 status and post-COVID-19 olfactory recovery. Both C19+ and C19- groups exhibited smell loss, but it was significantly larger in C19+ participants (mean±SD, C19+: -82.5±27.2 points; C19-: -59.8±37.7). Smell loss during illness was the best predictor of COVID-19 in both univariate and multivariate models (ROC AUC=0.72). Additional variables provide negligible model improvement. VAS ratings of smell loss were more predictive than binary chemosensory yes/no-questions or other cardinal symptoms (e.g., fever). Olfactory recovery within 40 days of respiratory symptom onset was reported for ~50% of participants and was best predicted by time since respiratory symptom onset. We find that quantified smell loss is the best predictor of COVID-19 amongst those with symptoms of respiratory illness. To aid clinicians and contact tracers in identifying individuals with a high likelihood of having COVID-19, we propose a novel 0-10 scale to screen for recent olfactory loss, the ODoR-19. We find that numeric ratings ≤2 indicate high odds of symptomatic COVID-19 (4

Published
2020
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