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Documents disponibles écrits par cet auteur (5)
Faire une suggestion Affiner la rechercheCorrection to: Exploring Social Biomarkers in HighFunctioning Adults with Autism and Asperger's Versus Healthy Controls: A CrossSectional Analysis / Marta DEL VALLE RUBIDO in Journal of Autism and Developmental Disorders, 50-12 (December 2020)
Titre : Correction to: Exploring Social Biomarkers in HighFunctioning Adults with Autism and Asperger's Versus Healthy Controls: A CrossSectional Analysis Type de document : texte imprimé Auteurs : Marta DEL VALLE RUBIDO, Auteur ; Eric HOLLANDER, Auteur ; James T. MCCRACKEN, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur Article en page(s) : p.4431-4432 Langues : Anglais (eng) Index. décimale : PER Périodiques Résumé : The original version of this article unfortunately contained a mistake in CI values in Table 2. En ligne : http://dx.doi.org/10.1007/s10803-020-04522-3 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=434
in Journal of Autism and Developmental Disorders > 50-12 (December 2020) . - p.4431-4432[article] Correction to: Exploring Social Biomarkers in HighFunctioning Adults with Autism and Asperger's Versus Healthy Controls: A CrossSectional Analysis [texte imprimé] / Marta DEL VALLE RUBIDO, Auteur ; Eric HOLLANDER, Auteur ; James T. MCCRACKEN, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur . - p.4431-4432.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 50-12 (December 2020) . - p.4431-4432
Index. décimale : PER Périodiques Résumé : The original version of this article unfortunately contained a mistake in CI values in Table 2. En ligne : http://dx.doi.org/10.1007/s10803-020-04522-3 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=434
Titre : Exploring Social Biomarkers in High-Functioning Adults with Autism and Asperger's Versus Healthy Controls: A Cross-Sectional Analysis Type de document : texte imprimé Auteurs : Marta DEL VALLE RUBIDO, Auteur ; Eric HOLLANDER, Auteur ; James T. MCCRACKEN, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur Article en page(s) : p.4412-4430 Langues : Anglais (eng) Mots-clés : Biomarker Eye movement Olfactory Social cognition Curemark, Coronado Biosciences, Forest, Simons Foundation, Foundation for Prader Willi Research, and the Orphan Products Division of the Food and Drug Administration, and has intellectual property relating to oxytocin and autism. FS has provided consultation to Roche and Janssen Pharmaceutical and has received research grants from Roche, NIH, and the Simons Foundation. JTM has served as a consultant for Roche and Dart Neuroscience, has received research grants from Roche, and has received study drug from Shire and AstraZeneca. FS has received research funding from Roche and Janssen Pharmaceuticals. MVR, DU, JN, LB, OK, SS and PF are full-time employees of F. Hoffmann-La Roche. Index. décimale : PER Périodiques Résumé : Biomarkers for autism spectrum disorder (ASD) are lacking but would facilitate drug development for the core deficits of the disorder. We evaluated markers proposed for characterization of differences in social communication and interaction in adults with ASD versus healthy controls (HC) for utility as biomarkers. Data pooled from an observational study and baseline data from a placebo-controlled study were analyzed. Between-group differences were observed in eye-tracking tasks for activity monitoring, biomotion, human activity preference, composite score (p = 0.0001-0.037) and pupillometry (various tasks, p = 0.017-0.05). Impaired olfaction was more common in the ASD sample versus HC (p = 0.018). Our preliminary results suggest the potential use for stratification and response sub-analyses outcome-prediction of specific eye-tracking tasks, pupillometry and olfaction tests in ASD trials. En ligne : http://dx.doi.org/10.1007/s10803-020-04493-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=434
in Journal of Autism and Developmental Disorders > 50-12 (December 2020) . - p.4412-4430[article] Exploring Social Biomarkers in High-Functioning Adults with Autism and Asperger's Versus Healthy Controls: A Cross-Sectional Analysis [texte imprimé] / Marta DEL VALLE RUBIDO, Auteur ; Eric HOLLANDER, Auteur ; James T. MCCRACKEN, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur . - p.4412-4430.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 50-12 (December 2020) . - p.4412-4430
Mots-clés : Biomarker Eye movement Olfactory Social cognition Curemark, Coronado Biosciences, Forest, Simons Foundation, Foundation for Prader Willi Research, and the Orphan Products Division of the Food and Drug Administration, and has intellectual property relating to oxytocin and autism. FS has provided consultation to Roche and Janssen Pharmaceutical and has received research grants from Roche, NIH, and the Simons Foundation. JTM has served as a consultant for Roche and Dart Neuroscience, has received research grants from Roche, and has received study drug from Shire and AstraZeneca. FS has received research funding from Roche and Janssen Pharmaceuticals. MVR, DU, JN, LB, OK, SS and PF are full-time employees of F. Hoffmann-La Roche. Index. décimale : PER Périodiques Résumé : Biomarkers for autism spectrum disorder (ASD) are lacking but would facilitate drug development for the core deficits of the disorder. We evaluated markers proposed for characterization of differences in social communication and interaction in adults with ASD versus healthy controls (HC) for utility as biomarkers. Data pooled from an observational study and baseline data from a placebo-controlled study were analyzed. Between-group differences were observed in eye-tracking tasks for activity monitoring, biomotion, human activity preference, composite score (p = 0.0001-0.037) and pupillometry (various tasks, p = 0.017-0.05). Impaired olfaction was more common in the ASD sample versus HC (p = 0.018). Our preliminary results suggest the potential use for stratification and response sub-analyses outcome-prediction of specific eye-tracking tasks, pupillometry and olfaction tests in ASD trials. En ligne : http://dx.doi.org/10.1007/s10803-020-04493-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=434
Titre : In Search of Biomarkers for Autism Spectrum Disorder Type de document : texte imprimé Auteurs : Marta DEL VALLE RUBIDO, Auteur ; James T. MCCRACKEN, Auteur ; Eric HOLLANDER, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur Article en page(s) : p.1567-1579 Langues : Anglais (eng) Mots-clés : biomarker eye movement olfactory social cognition Index. décimale : PER Périodiques Résumé : Autism Spectrum Disorder (ASD) lacks validated measures of core social functions across development stages suitable for clinical trials. We assessed the concurrent validity between ASD clinical measures and putative biomarkers of core deficits, and their feasibility of implementation in human studies. Datasets from two adult ASD studies were combined (observational study [n = 19] and interventional study baseline data [n = 19]). Potential biomarkers included eye-tracking, olfaction, and auditory and visual emotion recognition assessed via the Affective Speech Recognition test (ASR) and Reading-the-Mind-in-the-Eyes Test (RMET). Current functioning was assessed with intelligence quotient (IQ), adaptive skill testing, and behavioral ratings. Autism severity was determined by the Autism Diagnostic Observation Scale-2 and Social Communication Interaction Test (SCIT). Exploratory measures showed varying significant associations across ASD severity, adaptive skills, and behavior. Eye tracking endpoints showed little relationship to adaptive ability but correlated with severity and behavior. ASR scores significantly correlated with most adaptive behavior domains, as well as severity. Olfaction predicted visual and auditory emotion recognition. SCIT scores related moderately to multiple severity domains, and was the only measure not related with IQ. RMET accuracy was less related to ASD features. Eye tracking, SCIT, and ASR showed high test-retest reliability. We documented associations of proximal biomarkers of social functioning with multiple ASD dimensions. With the exception of SCIT, most correlations were modest, limiting utility as proxy measures of social communication. Feasibility and reliability were high for eye-tracking, ASR, and SCIT. Overall, several novel experimental paradigms showed potential as social biomarkers or surrogate markers in ASD. Autism Research 2018, 11: 1567-1579. (c) 2018 The Authors. Autism Research published by International Society for Autism Research and Wiley Periodicals, Inc. LAY SUMMARY: More accurate measurements of treatment effects are needed to help the development of new drug treatments for autism spectrum disorders (ASD). This study evaluates the relationship between assessments designed to measure behaviors associated with social communication and cognition in ASD with clinical and diagnostic assessments of symptom severity as well as their implementation. The assessments including eye-tracking, auditory and visual social stimuli recognition, and olfaction identification showed potential for use in the evaluation of treatments for social difficulties in ASD. En ligne : http://dx.doi.org/10.1002/aur.2026 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=370
in Autism Research > 11-11 (November 2018) . - p.1567-1579[article] In Search of Biomarkers for Autism Spectrum Disorder [texte imprimé] / Marta DEL VALLE RUBIDO, Auteur ; James T. MCCRACKEN, Auteur ; Eric HOLLANDER, Auteur ; Frederick SHIC, Auteur ; Jana NOELDEKE, Auteur ; Lauren BOAK, Auteur ; Omar KHWAJA, Auteur ; Shamil SADIKHOV, Auteur ; Paulo FONTOURA, Auteur ; Daniel UMBRICHT, Auteur . - p.1567-1579.
Langues : Anglais (eng)
in Autism Research > 11-11 (November 2018) . - p.1567-1579
Mots-clés : biomarker eye movement olfactory social cognition Index. décimale : PER Périodiques Résumé : Autism Spectrum Disorder (ASD) lacks validated measures of core social functions across development stages suitable for clinical trials. We assessed the concurrent validity between ASD clinical measures and putative biomarkers of core deficits, and their feasibility of implementation in human studies. Datasets from two adult ASD studies were combined (observational study [n = 19] and interventional study baseline data [n = 19]). Potential biomarkers included eye-tracking, olfaction, and auditory and visual emotion recognition assessed via the Affective Speech Recognition test (ASR) and Reading-the-Mind-in-the-Eyes Test (RMET). Current functioning was assessed with intelligence quotient (IQ), adaptive skill testing, and behavioral ratings. Autism severity was determined by the Autism Diagnostic Observation Scale-2 and Social Communication Interaction Test (SCIT). Exploratory measures showed varying significant associations across ASD severity, adaptive skills, and behavior. Eye tracking endpoints showed little relationship to adaptive ability but correlated with severity and behavior. ASR scores significantly correlated with most adaptive behavior domains, as well as severity. Olfaction predicted visual and auditory emotion recognition. SCIT scores related moderately to multiple severity domains, and was the only measure not related with IQ. RMET accuracy was less related to ASD features. Eye tracking, SCIT, and ASR showed high test-retest reliability. We documented associations of proximal biomarkers of social functioning with multiple ASD dimensions. With the exception of SCIT, most correlations were modest, limiting utility as proxy measures of social communication. Feasibility and reliability were high for eye-tracking, ASR, and SCIT. Overall, several novel experimental paradigms showed potential as social biomarkers or surrogate markers in ASD. Autism Research 2018, 11: 1567-1579. (c) 2018 The Authors. Autism Research published by International Society for Autism Research and Wiley Periodicals, Inc. LAY SUMMARY: More accurate measurements of treatment effects are needed to help the development of new drug treatments for autism spectrum disorders (ASD). This study evaluates the relationship between assessments designed to measure behaviors associated with social communication and cognition in ASD with clinical and diagnostic assessments of symptom severity as well as their implementation. The assessments including eye-tracking, auditory and visual social stimuli recognition, and olfaction identification showed potential for use in the evaluation of treatments for social difficulties in ASD. En ligne : http://dx.doi.org/10.1002/aur.2026 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=370
Titre : A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABA(A)-α5 NAM (basmisanil) on intellectual disability associated with Down syndrome Type de document : texte imprimé Auteurs : Celia GOELDNER, Auteur ; Priya S. KISHNANI, Auteur ; Brian G. SKOTKO, Auteur ; Julian Lirio CASERO, Auteur ; Joerg F. HIPP, Auteur ; Michael DERKS, Auteur ; Maria-Clemencia HERNANDEZ, Auteur ; Omar KHWAJA, Auteur ; Sian LENNON-CHRIMES, Auteur ; Jana NOELDEKE, Auteur ; Sabine PELLICER, Auteur ; Lisa SQUASSANTE, Auteur ; Jeannie VISOOTSAK, Auteur ; Christoph WANDEL, Auteur ; Paulo FONTOURA, Auteur ; Xavier Liogier D'ARDHUY, Auteur ; CLEMATIS STUDY GROUP, Auteur Langues : Anglais (eng) Mots-clés : Adolescent Child Child, Preschool Down Syndrome/complications/drug therapy Humans Intellectual Disability/complications/drug therapy Morpholines Oxazoles Pyridines Quality of Life Treatment Outcome Young Adult gamma-Aminobutyric Acid/therapeutic use Adaptive behavior Cognition Down syndrome Eeg GABAA-α5 Khwaja, X Liogier d’Ardhuy, J Noeldeke, S Pellicer, L Squassante, C Wandel were employees of F.Hoffmann-La Roche AG Switzerland M Derks and S Lennon-Chrimes were employees of Roche Products Ltd. UK J Visootsak was an employee of Roche New York. All employees (former and current) may be eligible for stock and stock options. P S Kishnani has no disclosures for Down syndrome-related research. J Lirio Casero has no disclosures. B G Skotko occasionally consults on the topic of Down syndrome through the Gerson Lehrman Group. He receives remuneration from Down syndrome non-profit organizations for speaking engagements and associated travel expenses. Dr. Skotko receives annual royalties from Woodbine House, Inc., for the publication of his book, Fasten Your Seatbelt: A Crash Course on Down Syndrome for Brothers and Sisters. Within the past 2 years, he has also received research funding from AC Immune and LuMind Research Down Syndrome Foundation to conduct clinical trials for people with Down syndrome. Dr. Skotko is occasionally asked to serve as an expert witness for legal cases where Down syndrome is discussed. Dr. Skotko serves in a non-paid capacity on the Honorary Board of Directors for the Massachusetts Down Syndrome Congress and the Professional Advisory Committee for the National Center for Prenatal and Postnatal Down Syndrome Resources. Dr. Skotko has a sister with Down syndrome. Index. décimale : PER Périodiques Résumé : BACKGROUND: There are currently no pharmacological therapies to address the intellectual disability associated with Down syndrome. Excitatory/inhibitory imbalance has been hypothesized to contribute to impairments in cognitive functioning in Down syndrome. Negative modulation of the GABA(A)-α5 receptor is proposed as a mechanism to attenuate GABAergic function and restore the excitatory/inhibitory balance. METHODS: Basmisanil, a selective GABA(A)-α5 negative allosteric modulator, was evaluated at 120 mg or 240 mg BID (80 or 160 mg for 12-13 years) in a 6-month, randomized, double-blind, placebo-controlled phase II trial (Clematis) for efficacy and safety in adolescents and young adults with Down syndrome. The primary endpoint was based on a composite analysis of working memory (Repeatable Battery for the Assessment of Neuropsychological Scale [RBANS]) and independent functioning and adaptive behavior (Vineland Adaptive Behavior Scales [VABS-II] or the Clinical Global Impression-Improvement [CGI-I]). Secondary measures included the Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P), Clinical Evaluation of Language Fundamentals (CELF-4), and Pediatric Quality of Life Inventory (Peds-QL). EEG was conducted for safety monitoring and quantitatively analyzed in adolescents. RESULTS: Basmisanil was safe and well-tolerated; the frequency and nature of adverse events were similar in basmisanil and placebo arms. EEG revealed treatment-related changes in spectral power (increase in low ~ 4-Hz and decrease in high ~ 20-Hz frequencies) providing evidence of functional target engagement. All treatment arms had a similar proportion of participants showing above-threshold improvement on the primary composite endpoint, evaluating concomitant responses in cognition and independent functioning (29% in placebo, 20% in low dose, and 25% in high dose). Further analysis of the individual measures contributing to the primary endpoint revealed no difference between placebo and basmisanil-treated groups in either adolescents or adults. There were also no differences across the secondary endpoints assessing changes in executive function, language, or quality of life. CONCLUSIONS: Basmisanil did not meet the primary efficacy objective of concomitant improvement on cognition and adaptive functioning after 6 months of treatment, despite evidence for target engagement. This study provides key learnings for future clinical trials in Down syndrome. TRIAL REGISTRATION: The study was registered on December 31, 2013, at clinicaltrials.gov as NCT02024789. En ligne : https://dx.doi.org/10.1186/s11689-022-09418-0 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=574
in Journal of Neurodevelopmental Disorders > 14 (2022)[article] A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABA(A)-α5 NAM (basmisanil) on intellectual disability associated with Down syndrome [texte imprimé] / Celia GOELDNER, Auteur ; Priya S. KISHNANI, Auteur ; Brian G. SKOTKO, Auteur ; Julian Lirio CASERO, Auteur ; Joerg F. HIPP, Auteur ; Michael DERKS, Auteur ; Maria-Clemencia HERNANDEZ, Auteur ; Omar KHWAJA, Auteur ; Sian LENNON-CHRIMES, Auteur ; Jana NOELDEKE, Auteur ; Sabine PELLICER, Auteur ; Lisa SQUASSANTE, Auteur ; Jeannie VISOOTSAK, Auteur ; Christoph WANDEL, Auteur ; Paulo FONTOURA, Auteur ; Xavier Liogier D'ARDHUY, Auteur ; CLEMATIS STUDY GROUP, Auteur.
Langues : Anglais (eng)
in Journal of Neurodevelopmental Disorders > 14 (2022)
Mots-clés : Adolescent Child Child, Preschool Down Syndrome/complications/drug therapy Humans Intellectual Disability/complications/drug therapy Morpholines Oxazoles Pyridines Quality of Life Treatment Outcome Young Adult gamma-Aminobutyric Acid/therapeutic use Adaptive behavior Cognition Down syndrome Eeg GABAA-α5 Khwaja, X Liogier d’Ardhuy, J Noeldeke, S Pellicer, L Squassante, C Wandel were employees of F.Hoffmann-La Roche AG Switzerland M Derks and S Lennon-Chrimes were employees of Roche Products Ltd. UK J Visootsak was an employee of Roche New York. All employees (former and current) may be eligible for stock and stock options. P S Kishnani has no disclosures for Down syndrome-related research. J Lirio Casero has no disclosures. B G Skotko occasionally consults on the topic of Down syndrome through the Gerson Lehrman Group. He receives remuneration from Down syndrome non-profit organizations for speaking engagements and associated travel expenses. Dr. Skotko receives annual royalties from Woodbine House, Inc., for the publication of his book, Fasten Your Seatbelt: A Crash Course on Down Syndrome for Brothers and Sisters. Within the past 2 years, he has also received research funding from AC Immune and LuMind Research Down Syndrome Foundation to conduct clinical trials for people with Down syndrome. Dr. Skotko is occasionally asked to serve as an expert witness for legal cases where Down syndrome is discussed. Dr. Skotko serves in a non-paid capacity on the Honorary Board of Directors for the Massachusetts Down Syndrome Congress and the Professional Advisory Committee for the National Center for Prenatal and Postnatal Down Syndrome Resources. Dr. Skotko has a sister with Down syndrome. Index. décimale : PER Périodiques Résumé : BACKGROUND: There are currently no pharmacological therapies to address the intellectual disability associated with Down syndrome. Excitatory/inhibitory imbalance has been hypothesized to contribute to impairments in cognitive functioning in Down syndrome. Negative modulation of the GABA(A)-α5 receptor is proposed as a mechanism to attenuate GABAergic function and restore the excitatory/inhibitory balance. METHODS: Basmisanil, a selective GABA(A)-α5 negative allosteric modulator, was evaluated at 120 mg or 240 mg BID (80 or 160 mg for 12-13 years) in a 6-month, randomized, double-blind, placebo-controlled phase II trial (Clematis) for efficacy and safety in adolescents and young adults with Down syndrome. The primary endpoint was based on a composite analysis of working memory (Repeatable Battery for the Assessment of Neuropsychological Scale [RBANS]) and independent functioning and adaptive behavior (Vineland Adaptive Behavior Scales [VABS-II] or the Clinical Global Impression-Improvement [CGI-I]). Secondary measures included the Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P), Clinical Evaluation of Language Fundamentals (CELF-4), and Pediatric Quality of Life Inventory (Peds-QL). EEG was conducted for safety monitoring and quantitatively analyzed in adolescents. RESULTS: Basmisanil was safe and well-tolerated; the frequency and nature of adverse events were similar in basmisanil and placebo arms. EEG revealed treatment-related changes in spectral power (increase in low ~ 4-Hz and decrease in high ~ 20-Hz frequencies) providing evidence of functional target engagement. All treatment arms had a similar proportion of participants showing above-threshold improvement on the primary composite endpoint, evaluating concomitant responses in cognition and independent functioning (29% in placebo, 20% in low dose, and 25% in high dose). Further analysis of the individual measures contributing to the primary endpoint revealed no difference between placebo and basmisanil-treated groups in either adolescents or adults. There were also no differences across the secondary endpoints assessing changes in executive function, language, or quality of life. CONCLUSIONS: Basmisanil did not meet the primary efficacy objective of concomitant improvement on cognition and adaptive functioning after 6 months of treatment, despite evidence for target engagement. This study provides key learnings for future clinical trials in Down syndrome. TRIAL REGISTRATION: The study was registered on December 31, 2013, at clinicaltrials.gov as NCT02024789. En ligne : https://dx.doi.org/10.1186/s11689-022-09418-0 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=574
