Autism Innovative Medicine Studies – 2 – Trials


Autism spectrum disorders (ASD) affect around 1 % of the population and are characterised by difficulties in social interactions and communication as well as repetitive behaviours. The precise symptoms and their severity vary widely from one person to another; some are only mildly afflicted and can lead relatively independent lives, while others are severely disabled and require a lot of specialist care. People with ASD often have other conditions, including epilepsy, depression, anxiety and attention deficit hyperactivity disorder (ADHD). Today, there are no drugs designed specifically to treat ASD; instead, those affected are treated with medicines designed for other conditions.

AIMS-2-TRIALS aims to improve outcomes for people with ASD. To do this it will create a pipeline for developing, testing and implementing new treatments for ASD with stakeholder involvement at each stage. The project will set up a global clinical trial network for ASD to validate biological markers and endpoints to reliably show whether or not a treatment is effective and appropriate for ASD.

The project brings together experts from universities, university hospitals, pharmaceutical companies, patient groups, not-for-profit foundations, and small and medium-sized enterprises.

Achievements & News

IMI Associated Partner SFARI: ‘Collaborative efforts are invaluable for advancing autism science’

IMI Associated Partner the Simons Foundation Autism Research Initiative (SFARI) is a research programme whose mission is 'to improve the understanding, diagnosis and treatment of autism spectrum disorders by funding innovative research of the highest quality and relevance.' ### The project started working with IMI through the IMI1 project EU-AIMS, and is now an Associated Partner in the IMI2 project AIMS-2-TRIALS.

‘In addition to expanding and sharing our SPARK cohort — which will be a community of over 50 000 individuals with autism, and their families, for a majority of whom we will have genomic data — we have provided supplies of an experimental medication that is being tested in a clinical trial run by AIMS-2-TRIALS,’ says SFARI Deputy Director of Clinical Research, Paul Wang, in an interview with the IMI Programme Office. 

‘Autism is enormously complex, and we believe that collaborative efforts spanning academia, industry, and the non-profit sectors, are invaluable for advancing autism science. Indeed, we strive to have representation from all of these sectors in many of our own workshops and other initiatives,’ he says.

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COVID exacerbates healthcare inequalities for autistic people

Researchers from AIMS-2-TRIALS have published a report that shows that the COVID-19 pandemic has further exacerbated existing healthcare inequalities for autistic people and has likely contributed to disproportionate increases in morbidity and mortality, mental health/behavioural difficulties and reduced quality of life. ###The researchers arrived at this conclusion after studying COVID-19 policies from 15 countries and analysing data from a survey of over 1 000 autistic people and caregivers. Writing in BMJ OPEN, the team explains that autistic people experienced four significant barriers accessing COVID-19 services:

  • despite being at elevated risk for severe illness due to co-occurring health conditions, there was a lack of accessibility of COVID-19 testing (e.g. lack of reasonable adjustments/provision of preparatory materials);
  • many COVID-19 outpatient and inpatient treatment services were reported to be inaccessible – predominantly resulting from individual differences in communication needs;
  • ICU triage protocols in many European countries may have (directly or indirectly) resulted in discriminatory exclusion from lifesaving treatments;
  • interruptions to standard health and social care left over 70% of autistic people without everyday support, in the absence of appropriate mitigation measures.

Dr Bethany Oakley of Kings College London said: ‘Increasing service capacity and investing in resilience planning should be the primary response for decision makers to make sure that there is equal access to hospital and intensive care resources, across the population, and that steps are taken to make sure that autistic people and all those with developmental differences are not put at a disadvantage.’

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Are there differences in the brains of autistic men and women?

Around three times as many males are diagnosed with autism than females, which suggests that sex-related biological factors play a key role in its development. However, little is known about the ways that autistic males and females differ in terms of brain structure and function.###

AIMS-2-TRIALS researchers, in collaboration with colleagues from the Child Mind Institute, explored this further using resting-state functional magnetic resonance imaging (R-fMRI) to study brain function in three large samples of autistic males and females and a control group of non-autistic people. They used one sample for discovery of new information and two additional large samples to see if those findings could be repeated (i.e. replicated).

Across these three samples, the researchers found that both neurotypical males and autistic people showed reduced resting-state brain function in the so-called ‘default network’, a network that is active when we engage in social cognition or thoughts about ourselves. Additionally, in the discovery sample and in one of the largest of the two replication samples, it was shown that connections crossing between the two halves of the brain in the visual cortex are reduced in autistic females, while autistic males are not different from males who are not autistic. The results suggest that many autistic people may have different interactions between the two hemispheres of their brain when compared to non-autistic people. This reflects a combination of effects, including some that appear to be unrelated to sex, and some in which there is an interaction between sex and autism diagnosis. Each of these effects appears specific to a different system in the brain.

Until now, lack of replication of imaging findings has hampered brain imaging research in autism. This study, which included replication analyses, highlights that autistic people may have non-typical interactions in the connections between their brain’s hemispheres. Further, these findings may shed light on the mechanisms underlying sex-differences in autism. The research is published in the journal Molecular Autism.

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EFPIA companies
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Novartis Pharma AG, Basel, Switzerland
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
  • UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Associazione Oasi Maria SS. Onlus, Troina, Italy
  • Autisme-Europe Aisbl, Bruxelles, Belgium
  • Birkbeck College - University Of London, London, United Kingdom
  • Centre Hospitalier Regional Universitaire De Tours, Tours, France
  • Commissariat A L Energie Atomique Et Aux Energies Alternatives, Paris, France
  • Fondazione Stella Maris, Pisa, Italy
  • Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer, Barcelona, Spain
  • Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu, Esplugues de Llobregat, Spain
  • Fundazioa Policlinica Gipuzkoa Fundacion, Donostia / San Sebastián, Spain
  • Guys And St Thomas' Nhs Foundationtrust, London, United Kingdom
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Institut Pasteur, Paris, France
  • Irccs - Associazione La Nostra Famiglia 'Istituto Scientifico Eugenio Medea', Ponte Lambro, Italy
  • Johann Wolfgang Goethe-Universitaet Frankfurt Am Main, Frankfurt am Main, Germany
  • Karolinska Institutet, Stockholm, Sweden
  • King'S College London, London, United Kingdom
  • Klinikum Rechts Der Isar Der Technischen Universitat Munchen, Muenchen, Germany
  • Ospedale Pediatrico Bambino Gesu, Rome, Italy
  • Rijksuniversiteit Groningen, Groningen, Netherlands
  • Servicio Madrileno De Salud, Madrid, Spain
  • Stellenbosch University, Stellenbosch, South Africa
  • Stichting Buro Ecnp, Utrecht, Netherlands
  • Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
  • The University Of Edinburgh, Edinburgh, United Kingdom
  • Trinity College Dublin, Dublin, Ireland
  • Universidad De Salamanca, Salamanca, Spain
  • Universidade De Coimbra, Coimbra, Portugal
  • Universitaet Ulm, Ulm, Germany
  • Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts, Goettingen, Germany
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Universitat Basel, Basel, Switzerland
  • Universitatsklinikum Heidelberg, Heidelberg, Germany
  • Universiteit Gent, Gent, Belgium
  • University Of Bristol, Bristol, United Kingdom
  • University Of Glasgow, Glasgow, United Kingdom
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
  • University of Cambridge, Cambridge, United Kingdom
  • University of Oxford, Oxford, United Kingdom
  • Uppsala Universitet, Uppsala, Sweden
  • Zentralinstitut Fuer Seelische Gesundheit, Mannheim, Germany
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Arttic, Paris, France
  • Biosci Consulting Bvba, Maasmechelen, Belgium
  • Demcon Life Sciences & Health Enschede BV, Enschede, Netherlands
  • Noldus Information Technology BV, Wageningen, Netherlands
  • Starlab Barcelona SL, Barcelona, Spain
Associated partners
  • Autism Speaks Inc. Non Profit Corporation, Princeton, NJ, United States
  • Autistica, London, United Kingdom
  • The Simons Foundation, Inc, New York, United States
Third parties
  • Arttic Innovation GMBH, Munchen, Germany
  • Demcon Flex Center BV, Enschede, Netherlands
  • Demcon Innovation & Technology B.V., Enschede, Netherlands
  • Demcon Life Sciences & Healtheindhoven B.V., Best, Netherlands
  • Demcon Macawi Respiratory Systems BV, Enschede, Netherlands
  • Demcon Production BV, Enschede, Netherlands
  • Greater Glasgow Health Board, Glasgow, United Kingdom
  • Hospital Clinic De Barcelona, Barcelona, Spain
  • Lothian Health Board, Edinburgh, United Kingdom

NameEU funding in €
Arttic555 093
Assistance Publique Hopitaux De Paris1 027 102
Associazione Oasi Maria SS. Onlus3 000
Autisme-Europe Aisbl267 470
Biosci Consulting Bvba192 344
Birkbeck College - University Of London3 039 131
Centre Hospitalier Regional Universitaire De Tours24 125
Commissariat A L Energie Atomique Et Aux Energies Alternatives1 056 714
Demcon Life Sciences & Health Enschede BV196 653
Fondazione Stella Maris68 125
Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer125 020
Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu3 000
Fundazioa Policlinica Gipuzkoa Fundacion68 125
Guys And St Thomas' Nhs Foundationtrust3 000
Institut National De La Sante Et De La Recherche Medicale847 916
Institut Pasteur2 661 581
Irccs - Associazione La Nostra Famiglia 'Istituto Scientifico Eugenio Medea'3 000
Johann Wolfgang Goethe-Universitaet Frankfurt Am Main780 203
Karolinska Institutet1 199 067
King'S College London19 765 013
Klinikum Rechts Der Isar Der Technischen Universitat Munchen208 750
Noldus Information Technology BV271 353
Ospedale Pediatrico Bambino Gesu3 000
Rijksuniversiteit Groningen833 975
Servicio Madrileno De Salud5 397 646
Starlab Barcelona SL122 500
Stellenbosch University667 778
Stichting Buro Ecnp187 499
Stichting Radboud Universitair Medisch Centrum4 465 007
The University Of Edinburgh7 832
Trinity College Dublin390 695
Universidad De Salamanca181 731
Universidade De Coimbra777 016
Universitaet Ulm802 188
Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts68 125
Universitair Medisch Centrum Utrecht1 097 648
Universitat Basel1 199 929
Universitatsklinikum Heidelberg3 000
Universiteit Gent954 429
University Of Bristol51 813
University of Cambridge2 797 033
University Of Glasgow108 969
University Of Newcastle Upon Tyne138 969
University of Oxford751 011
Uppsala Universitet149 995
Zentralinstitut Fuer Seelische Gesundheit920 245
Third parties
NameFunding in €
Arttic Innovation GMBH121 326
Demcon Flex Center BV6 959
Demcon Innovation & Technology B.V.5 111
Demcon Life Sciences & Healtheindhoven B.V.100 806
Demcon Macawi Respiratory Systems BV169 055
Demcon Production BV1 886
Greater Glasgow Health Board30 000
Hospital Clinic De Barcelona91 813
Lothian Health Board29 230
Total Cost55 000 004