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2. The EU-AIMS Longitudinal European Autism Project (LEAP): clinical characterisation

Author

Charman, T., Loth, Eva, Tillmann, Julian, Crawley, Daisy, Wooldridge, C., Goyard, David, Ahmad, Jumana, Auyeung, Bonnie, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen,Simon, Baumeister, Sarah, Beckmann, Christian, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, Brammer, Michael, Brandeis, Daniel, Brogna, Claudia, De Bruijn, Y., Chakrabarti,B., Cornelissen, Ineke, Acqua, Flavio Dell, Dumas, G., Durston, Sarah, Ecker,C., Faulkner, J., Frouin, Vincent, Garces, Pilar, Ham, Lindsay M., Hayward, Hannah, Hipp, Joerg, Holt, R. J., Isaksson, Johan, Johnson, Mark H., Jones, Emily J. H., Kundu, Prantik, Lai,Meng-Chuan, D'Ardhuy, X. L., Lombardo, Michael V., Lythgoe, David J., Mandl, Rene, Mason, Luke, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan J., Persico, Antonio M., Ruggeri, B., Ruigrok,Amber N. V., Sabet, Jessica, Sacco, Roberto, Caceres, Antonia San Jose, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams,Steven C. R., Zwiers, Marcel P., Spooren, Will, Murphy,Declan G. M., Buitelaar, Jan K., Lombardo,Michael V., Institute of Psychiatry, Psychology & Neuroscience, King's College London, King‘s College London, Service NEUROSPIN ( NEUROSPIN ), Direction de Recherche Fondamentale (CEA) ( DRF (CEA) ), Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Université Paris-Saclay-Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Université Paris-Saclay, University of Edinburgh, Autism Research Centre and Section of Developmental Psychiatry, University of Cambridge [UK] ( CAM ), University Medical Center [Utrecht], Universität Heidelberg [Heidelberg], Medizinische Fakultät Mannheim, Radboud University Medical Center [Nijmegen], Karolinska Institutet [Stockholm], Génétique humaine et Fonctions cognitives - Human Genetics and Cognitive Functions, Institut Pasteur [Paris]-Centre National de la Recherche Scientifique ( CNRS ), Università Campus Bio-Medico di Roma / University Campus Bio-Medico of Rome ( UCBM ), University of Reading ( UOR ), Goethe-University Frankfurt am Main, Roche Pharma Research and Early Development [Basel] ( pRED ), F. Hoffmann-La Roche [Basel], Uppsala University, Centre for Brain and Cognitive Development [Birkbeck College], Birkbeck College [University of London], Icahn School of Medicine at Mount Sinai [New York], University of Toronto, University of Cyprus [Nicosia], Janssen Research & Development, University of Messina, This work was supported by EU-AIMS (European Autism Interventions), which receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115300, the resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme (grant FP7/2007-2013), from the European Federation of Pharmaceutical Industries and Associations companies’ inkind contributions, and from Autism Speaks., European Project : 115300,EC:FP7:SP1-JTI,IMI-JU-03-2010,EU-AIMS ( 2012 ), Service NEUROSPIN (NEUROSPIN), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), University of Cambridge [UK] (CAM), Department of Child and Adolescent Psychiatry and Psychotherapy [Mannheim], Universität Heidelberg [Heidelberg] = Heidelberg University, Stockholm County Council, Génétique humaine et fonctions cognitives - Human Genetics and Cognitive Functions (GHFC (UMR_3571 / U-Pasteur_1)), Institut Pasteur [Paris] (IP)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Università Campus Bio-Medico di Roma / University Campus Bio-Medico of Rome ( UCBM), University of Reading (UOR), Universitätsklinikum Frankfurt, Roche Pharma Research and Early Development [Basel] (pRED), University of London [London], Icahn School of Medicine at Mount Sinai [New York] (MSSM), University of Cyprus [Nicosia] (UCY), Donders Institute for Brain, Cognition and Behaviour, Radboud University [Nijmegen], This work was supported by EU-AIMS (European Autism Interventions), which receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115300, the resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme (grant FP7/2007-2013), from the European Federation of Pharmaceutical Industries and Associations companies’ in-kind contributions, and from Autism Speaks., European Project: 115300,EC:FP7:SP1-JTI,IMI-JU-03-2010,EU-AIMS(2012), Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Institut Pasteur [Paris]-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Radboud university [Nijmegen], Lombardo, Michael V. [0000-0001-6780-8619], Charman, Tony [0000-0003-1993-6549], Loth, Eva [0000-0001-9458-9167], Tillmann, Julian [0000-0001-9574-9855], Crawley, Daisy [0000-0001-9901-1110], Ahmad, Jumana [0000-0001-5271-0731], Banaschewski, Tobias [0000-0003-4595-1144], Baron-Cohen, Simon [0000-0001-9217-2544], Brogna, Claudia [0000-0002-9526-6367], Dumas, Guillaume [0000-0002-2253-1844], Hayward, Hannah [0000-0001-5552-2146], Hipp, Joerg [0000-0002-7875-2988], Isaksson, Johan [0000-0003-1033-2618], Johnson, Mark [0000-0003-4229-2585], Jones, Emily JH [0000-0001-5747-9540], Lai, Meng-Chuan [0000-0002-9593-5508], Lythgoe, David J [0000-0002-5078-9025], Moessnang, Carolin [0000-0003-4357-2706], Ruggeri, Barbara [0000-0002-6231-8829], Ruigrok, Amber [0000-0001-7711-8056], Simonoff, Emily [0000-0002-5450-0823], Toro, Roberto [0000-0002-6671-858X], Williams, Steve CR [0000-0003-4299-1941], Murphy, Declan GM [0000-0002-6664-7451], and Apollo - University of Cambridge Repository

Subjects
Parents, Male, [SDV]Life Sciences [q-bio], Autism, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Stress-related disorders Donders Center for Medical Neuroscience [Radboudumc 13], Individuality, Behaviours, Severity of Illness Index, lcsh:RC346-429, psyc, 0302 clinical medicine, Age, autism, autism spectrum disorder, behaviours, heterogeneity, IQ, phenotype, sex, molecular biology, developmental neuroscience, developmental biology, psychiatry and mental health, Surveys and Questionnaires, Longitudinal Studies, Autism spectrum disorder, Child, Psychiatry, Age, autism, autism spectrum disorder, behaviours, heterogeneity, IQ, phenotype, sex, molecular biology, developmental neuroscience, developmental biology, psychiatry and mental health, 05 social sciences, Neuropsychology, Age Factors, 220 Statistical Imaging Neuroscience, [SDV.NEU.SC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Cognitive Sciences, Cognition, Psychiatry and Mental health, Phenotype, Cohort, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Female, Sex, Psychology, 050104 developmental & child psychology, Adult, medicine.medical_specialty, Adolescent, BF, behavioral disciplines and activities, 150 000 MR Techniques in Brain Function, Psykiatri, 03 medical and health sciences, Genetic Heterogeneity, [ SHS.PSY ] Humanities and Social Sciences/Psychology, Sex Factors, Developmental Neuroscience, Severity of illness, mental disorders, medicine, Journal Article, Humans, 0501 psychology and cognitive sciences, Molecular Biology, lcsh:Neurology. Diseases of the nervous system, Neurodevelopmental disorders Donders Center for Medical Neuroscience [Radboudumc 7], Research, medicine.disease, R1, Clinical trial, Impulsive Behavior, Observational study, Self Report, Heterogeneity, 030217 neurology & neurosurgery, Biomarkers, Developmental Biology
Abstract

Background The EU-AIMS Longitudinal European Autism Project (LEAP) is to date the largest multi-centre, multi-disciplinary observational study on biomarkers for autism spectrum disorder (ASD). The current paper describes the clinical characteristics of the LEAP cohort and examines age, sex and IQ differences in ASD core symptoms and common co-occurring psychiatric symptoms. A companion paper describes the overall design and experimental protocol and outlines the strategy to identify stratification biomarkers. Methods From six research centres in four European countries, we recruited 437 children and adults with ASD and 300 controls between the ages of 6 and 30 years with IQs varying between 50 and 148. We conducted in-depth clinical characterisation including a wide range of observational, interview and questionnaire measures of the ASD phenotype, as well as co-occurring psychiatric symptoms. Results The cohort showed heterogeneity in ASD symptom presentation, with only minimal to moderate site differences on core clinical and cognitive measures. On both parent-report interview and questionnaire measures, ASD symptom severity was lower in adults compared to children and adolescents. The precise pattern of differences varied across measures, but there was some evidence of both lower social symptoms and lower repetitive behaviour severity in adults. Males had higher ASD symptom scores than females on clinician-rated and parent interview diagnostic measures but not on parent-reported dimensional measures of ASD symptoms. In contrast, self-reported ASD symptom severity was higher in adults compared to adolescents, and in adult females compared to males. Higher scores on ASD symptom measures were moderately associated with lower IQ. Both inattentive and hyperactive/impulsive ADHD symptoms were lower in adults than in children and adolescents, and males with ASD had higher levels of inattentive and hyperactive/impulsive ADHD symptoms than females. Conclusions The established phenotypic heterogeneity in ASD is well captured in the LEAP cohort. Variation both in core ASD symptom severity and in commonly co-occurring psychiatric symptoms were systematically associated with sex, age and IQ. The pattern of ASD symptom differences with age and sex also varied by whether these were clinician ratings or parent- or self-reported which has important implications for establishing stratification biomarkers and for their potential use as outcome measures in clinical trials. Electronic supplementary material The online version of this article (doi:10.1186/s13229-017-0145-9) contains supplementary material, which is available to authorized users.

Published
2017

3. The EU-AIMS Longitudinal European Autism Project (LEAP) : design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders.

Author

Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily J H, Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, de Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell', Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M, Hipp, Joerg, Holt, Rosemary J, Johnson, Mark H, Isaksson, Johan, Kundu, Prantik, Lai, Meng-Chuan, D'ardhuy, Xavier Liogier, Lombardo, Michael V, Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M, Ruigrok, Amber N V, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve C R, Zwiers, Marcel P, Spooren, Will, Murphy, Declan G M, Buitelaar, Jan K, Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily J H, Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, de Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell', Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M, Hipp, Joerg, Holt, Rosemary J, Johnson, Mark H, Isaksson, Johan, Kundu, Prantik, Lai, Meng-Chuan, D'ardhuy, Xavier Liogier, Lombardo, Michael V, Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M, Ruigrok, Amber N V, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve C R, Zwiers, Marcel P, Spooren, Will, Murphy, Declan G M, and Buitelaar, Jan K

Abstract

BACKGROUND: The tremendous clinical and aetiological diversity among individuals with autism spectrum disorder (ASD) has been a major obstacle to the development of new treatments, as many may only be effective in particular subgroups. Precision medicine approaches aim to overcome this challenge by combining pathophysiologically based treatments with stratification biomarkers that predict which treatment may be most beneficial for particular individuals. However, so far, we have no single validated stratification biomarker for ASD. This may be due to the fact that most research studies primarily have focused on the identification of mean case-control differences, rather than within-group variability, and included small samples that were underpowered for stratification approaches. The EU-AIMS Longitudinal European Autism Project (LEAP) is to date the largest multi-centre, multi-disciplinary observational study worldwide that aims to identify and validate stratification biomarkers for ASD. METHODS: LEAP includes 437 children and adults with ASD and 300 individuals with typical development or mild intellectual disability. Using an accelerated longitudinal design, each participant is comprehensively characterised in terms of clinical symptoms, comorbidities, functional outcomes, neurocognitive profile, brain structure and function, biochemical markers and genomics. In addition, 51 twin-pairs (of which 36 had one sibling with ASD) are included to identify genetic and environmental factors in phenotypic variability. RESULTS: Here, we describe the demographic characteristics of the cohort, planned analytic stratification approaches, criteria and steps to validate candidate stratification markers, pre-registration procedures to increase transparency, standardisation and data robustness across all analyses, and share some 'lessons learnt'. A clinical characterisation of the cohort is given in the companion paper (Charman et al., accepted). CONCLUSION: We expect that LEAP wil

Published
2017
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4. The EU-AIMS Longitudinal European Autism Project (LEAP): Design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders

Author

Ontwikkelingsstoornissen Ond., Brain, Onderzoeksgroep 8, Onderzoek Bob Oranje, Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily J.H., Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, De Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell, Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M., Hipp, Joerg, Holt, Rosemary J., Johnson, Mark H., Isaksson, Johan, Kundu, Prantik, Lai, Meng Chuan, D'Ardhuy, Xavier Liogier, Lombardo, Michael V., Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M., Ruigrok, Amber N V, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve C.R., Zwiers, Marcel P., Spooren, Will, Murphy, Declan G M, Buitelaar, Jan K., Ontwikkelingsstoornissen Ond., Brain, Onderzoeksgroep 8, Onderzoek Bob Oranje, Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily J.H., Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, De Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell, Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M., Hipp, Joerg, Holt, Rosemary J., Johnson, Mark H., Isaksson, Johan, Kundu, Prantik, Lai, Meng Chuan, D'Ardhuy, Xavier Liogier, Lombardo, Michael V., Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M., Ruigrok, Amber N V, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve C.R., Zwiers, Marcel P., Spooren, Will, Murphy, Declan G M, and Buitelaar, Jan K.

Published
2017

5. Identification and validation of biomarkers for autism spectrum disorders

Author

Loth, Eva, Spooren, Will, Ham, Lindsay M., Isaac, Maria B., Auriche-Benichou, Caroline, Banaschewski, Tobias, Baron-Cohen,Simon, Broich, Karl, Boelte, Sven, Bourgeron, Thomas, Charman, Tony, Collier, David, de Andres-Trelles, Fernando, Durston, Sarah, Ecker, Christine, Elferink, Andre, Haberkamp, Marion, Hemmings, Robert, Johnson, Mark H., Jones, Emily J. H., Khwaja, Omar S., Lenton, Sabine, Mason, Luke, Mantua, Valentina, Meyer-Lindenberg, Andreas, Lombardo, Michael V., O'Dwyer, Laurence, Okamoto, Koichi, Pandina, Gahan J., Pani, Luca, Persico, Antonio M., Simonoff, Emily, Tauscher-Wisniewski, Sitra, Llinares-Garcia, Jordi, Vamvakas, Spiros, Williams,Steven C. R., Buitelaar, Jan K., Murphy,Declan G. M., Lombardo,Michael V., and Lombardo, Michael V. [0000-0001-6780-8619]

Abstract

Autism spectrum disorder (ASD) is one of the most common neurodevelopmental disorders, but effective medical treatments for the core symptoms of the disorder are still lacking. According to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), the core symptoms of ASD comprise deficits in social communication and interaction, and repetitive and restricted behaviours, which include sensory abnormalities. Novel genetic and preclinical approaches now provide unprecedented opportunities to identify the underpinning pathophysiological mechanisms and aetiology-based treatment targets, as discussed in a Review article by Ghosh et al. (Drug discovery for autism spectrum disorder: challenges and opportunities. Nat. Rev. Drug Discov. 12, 777–790 (2013)1. This has led to more interest from the pharmaceutical industry in an area in which the overall risk of failure is seen as very high because key parameters of drug efficiency are not yet established and the regulatory environment is uncertain. For example, industry has recently invested in several pre-competitive projects, such as the European Union (EU) Innovative Medicines Initiative (IMI)-brokered public–private partnership EU-AIMS (European Autism Interventions — A Multicentre Study for Developing New Medications)2. 15 1 70 73 PT: J

Published
2016

6. The EU-AIMS Longitudinal European Autism Project (LEAP): design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders

Author

Loth, Eva, primary, Charman, Tony, additional, Mason, Luke, additional, Tillmann, Julian, additional, Jones, Emily J. H., additional, Wooldridge, Caroline, additional, Ahmad, Jumana, additional, Auyeung, Bonnie, additional, Brogna, Claudia, additional, Ambrosino, Sara, additional, Banaschewski, Tobias, additional, Baron-Cohen, Simon, additional, Baumeister, Sarah, additional, Beckmann, Christian, additional, Brammer, Michael, additional, Brandeis, Daniel, additional, Bölte, Sven, additional, Bourgeron, Thomas, additional, Bours, Carsten, additional, de Bruijn, Yvette, additional, Chakrabarti, Bhismadev, additional, Crawley, Daisy, additional, Cornelissen, Ineke, additional, Acqua, Flavio Dell’, additional, Dumas, Guillaume, additional, Durston, Sarah, additional, Ecker, Christine, additional, Faulkner, Jessica, additional, Frouin, Vincent, additional, Garces, Pilar, additional, Goyard, David, additional, Hayward, Hannah, additional, Ham, Lindsay M., additional, Hipp, Joerg, additional, Holt, Rosemary J., additional, Johnson, Mark H., additional, Isaksson, Johan, additional, Kundu, Prantik, additional, Lai, Meng-Chuan, additional, D’ardhuy, Xavier Liogier, additional, Lombardo, Michael V., additional, Lythgoe, David J., additional, Mandl, René, additional, Meyer-Lindenberg, Andreas, additional, Moessnang, Carolin, additional, Mueller, Nico, additional, O’Dwyer, Laurence, additional, Oldehinkel, Marianne, additional, Oranje, Bob, additional, Pandina, Gahan, additional, Persico, Antonio M., additional, Ruigrok, Amber N. V., additional, Ruggeri, Barbara, additional, Sabet, Jessica, additional, Sacco, Roberto, additional, Cáceres, Antonia San José, additional, Simonoff, Emily, additional, Toro, Roberto, additional, Tost, Heike, additional, Waldman, Jack, additional, Williams, Steve C. R., additional, Zwiers, Marcel P., additional, Spooren, Will, additional, Murphy, Declan G. M., additional, and Buitelaar, Jan K., additional

Published
2017
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7. Identification and validation of biomarkers for autism spectrum disorders

Author

Loth, Eva, primary, Spooren, Will, additional, Ham, Lindsay M., additional, Isaac, Maria B., additional, Auriche-Benichou, Caroline, additional, Banaschewski, Tobias, additional, Baron-Cohen, Simon, additional, Broich, Karl, additional, Bölte, Sven, additional, Bourgeron, Thomas, additional, Charman, Tony, additional, Collier, David, additional, de Andres-Trelles, Fernando, additional, Durston, Sarah, additional, Ecker, Christine, additional, Elferink, Andre, additional, Haberkamp, Marion, additional, Hemmings, Robert, additional, Johnson, Mark H., additional, Jones, Emily J. H., additional, Khwaja, Omar S., additional, Lenton, Sabine, additional, Mason, Luke, additional, Mantua, Valentina, additional, Meyer-Lindenberg, Andreas, additional, Lombardo, Michael V., additional, O'Dwyer, Laurence, additional, Okamoto, Koichi, additional, Pandina, Gahan J., additional, Pani, Luca, additional, Persico, Antonio M., additional, Simonoff, Emily, additional, Tauscher-Wisniewski, Sitra, additional, Llinares-Garcia, Jordi, additional, Vamvakas, Spiros, additional, Williams, Steve, additional, Buitelaar, Jan K., additional, and Murphy, Declan G. M., additional

Published
2015
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9. The EU-AIMS Longitudinal European Autism Project (LEAP): design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders

Author

Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily JH, Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, De Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell', Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M, Hipp, Joerg, Holt, Rosemary J, Johnson, Mark H, Isaksson, Johan, Kundu, Prantik, Lai, Meng-Chuan, D'ardhuy, Xavier Liogier, Lombardo, Michael V, Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M, Ruigrok, Amber NV, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve CR, Zwiers, Marcel P, Spooren, Will, Murphy, Declan GM, and Buitelaar, Jan K

Subjects
Adult, Male, Autism Spectrum Disorder, Individuality, Neuroimaging, Genetic Heterogeneity, Cognition, Genetics, Humans, EEG, Longitudinal Studies, Precision Medicine, Child, Saliva, Eye Movement Measurements, Patient Selection, Siblings, Brain, Magnetic Resonance Imaging, 3. Good health, Phenotype, FOS: Biological sciences, Female, Eye-tracking, Biomarkers, MRI, Hair
Abstract

BACKGROUND: The tremendous clinical and aetiological diversity among individuals with autism spectrum disorder (ASD) has been a major obstacle to the development of new treatments, as many may only be effective in particular subgroups. Precision medicine approaches aim to overcome this challenge by combining pathophysiologically based treatments with stratification biomarkers that predict which treatment may be most beneficial for particular individuals. However, so far, we have no single validated stratification biomarker for ASD. This may be due to the fact that most research studies primarily have focused on the identification of mean case-control differences, rather than within-group variability, and included small samples that were underpowered for stratification approaches. The EU-AIMS Longitudinal European Autism Project (LEAP) is to date the largest multi-centre, multi-disciplinary observational study worldwide that aims to identify and validate stratification biomarkers for ASD. METHODS: LEAP includes 437 children and adults with ASD and 300 individuals with typical development or mild intellectual disability. Using an accelerated longitudinal design, each participant is comprehensively characterised in terms of clinical symptoms, comorbidities, functional outcomes, neurocognitive profile, brain structure and function, biochemical markers and genomics. In addition, 51 twin-pairs (of which 36 had one sibling with ASD) are included to identify genetic and environmental factors in phenotypic variability. RESULTS: Here, we describe the demographic characteristics of the cohort, planned analytic stratification approaches, criteria and steps to validate candidate stratification markers, pre-registration procedures to increase transparency, standardisation and data robustness across all analyses, and share some 'lessons learnt'. A clinical characterisation of the cohort is given in the companion paper (Charman et al., accepted). CONCLUSION: We expect that LEAP will enable us to confirm, reject and refine current hypotheses of neurocognitive/neurobiological abnormalities, identify biologically and clinically meaningful ASD subgroups, and help us map phenotypic heterogeneity to different aetiologies.

10. The EU-AIMS Longitudinal European Autism Project (LEAP): design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders

Author

Loth, Eva, Charman, Tony, Mason, Luke, Tillmann, Julian, Jones, Emily JH, Wooldridge, Caroline, Ahmad, Jumana, Auyeung, Bonnie, Brogna, Claudia, Ambrosino, Sara, Banaschewski, Tobias, Baron-Cohen, Simon, Baumeister, Sarah, Beckmann, Christian, Brammer, Michael, Brandeis, Daniel, Bölte, Sven, Bourgeron, Thomas, Bours, Carsten, De Bruijn, Yvette, Chakrabarti, Bhismadev, Crawley, Daisy, Cornelissen, Ineke, Acqua, Flavio Dell', Dumas, Guillaume, Durston, Sarah, Ecker, Christine, Faulkner, Jessica, Frouin, Vincent, Garces, Pilar, Goyard, David, Hayward, Hannah, Ham, Lindsay M, Hipp, Joerg, Holt, Rosemary, Johnson, Mark, Isaksson, Johan, Kundu, Prantik, Lai, Meng-Chuan, D'ardhuy, Xavier Liogier, Lombardo, Michael V, Lythgoe, David J, Mandl, René, Meyer-Lindenberg, Andreas, Moessnang, Carolin, Mueller, Nico, O'Dwyer, Laurence, Oldehinkel, Marianne, Oranje, Bob, Pandina, Gahan, Persico, Antonio M, Ruigrok, Amber, Ruggeri, Barbara, Sabet, Jessica, Sacco, Roberto, Cáceres, Antonia San José, Simonoff, Emily, Toro, Roberto, Tost, Heike, Waldman, Jack, Williams, Steve CR, Zwiers, Marcel P, Spooren, Will, Murphy, Declan GM, and Buitelaar, Jan K

Subjects
Adult, Male, Autism Spectrum Disorder, Siblings, Patient Selection, Individuality, Brain, Neuroimaging, Magnetic Resonance Imaging, 3. Good health, Genetic Heterogeneity, Phenotype, Humans, Female, Longitudinal Studies, Precision Medicine, Saliva, Child, Eye Movement Measurements, Biomarkers, Hair

13. Identification and validation of biomarkers for autism spectrum disorders.

Author

Loth E, Spooren W, Ham LM, Isaac MB, Auriche-Benichou C, Banaschewski T, Baron-Cohen S, Broich K, Bölte S, Bourgeron T, Charman T, Collier D, de Andres-Trelles F, Durston S, Ecker C, Elferink A, Haberkamp M, Hemmings R, Johnson MH, Jones EJ, Khwaja OS, Lenton S, Mason L, Mantua V, Meyer-Lindenberg A, Lombardo MV, O'Dwyer L, Okamoto K, Pandina GJ, Pani L, Persico AM, Simonoff E, Tauscher-Wisniewski S, Llinares-Garcia J, Vamvakas S, Williams S, Buitelaar JK, and Murphy DG

Subjects
Adolescent, Adult, Biomarkers analysis, Child, Child, Preschool, Endophenotypes, Female, Humans, Male, Reproducibility of Results, Young Adult, Autism Spectrum Disorder metabolism
Published
2016
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