Autism Innovative Medicine Studies – 2 – Trials
Ongoing | IMI2 |


Start Date
End Date
IMI2 - Call 10
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
54 999 999
EFPIA in kind
2 654 856
Associated Partners
55 620 060
Total Cost
113 274 915


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

Are there differences in the brains of autistic men and women?
March 2021

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.

Find out more

Participants Show participants on map

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 SRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Assistance Publique Hopitaux De Paris, Paris, France
  • 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 Clinic Per A La Recerca Biomedica, Barcelona, Spain
  • Fundazioa Policlinica Gipuzkoa Fundacion, Donostia / San Sebastián, Spain
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Institut Pasteur, Paris, France
  • 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
  • Rijksuniversiteit Groningen, Groningen, Netherlands
  • Servicio Madrileno De Salud, Madrid, Spain
  • Stellenbosch University, Stellenbosch, South Africa
  • Stichting Buro Ecnp, Utrecht, Netherlands
  • Stichting Katholieke Universiteit, 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
  • 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 Advanced Mechatronics Enschede B.V., 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
  • Demcon Advanced Mechatronics Bestb.V., Best, Netherlands
  • Demcon Flex Center BV, Enschede, 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
Project leader
Christopher Chatham
Project coordinator
Declan Murphy
King'S College London