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

This paper reports design and baseline data, not validated biomarkers, treatment effects or clinical recommendations. People with moderate, severe or profound intellectual disability were excluded, so it says nothing about those groups. The control group had higher average IQ than the autism group, mainly because fewer controls were in the lower average IQ range, which may affect comparisons. Some planned tests were not obtained for many participants, especially optional scans and later added tasks, because level 3 measures were omitted first when time ran short, technical problems occurred, or a participant wanted to stop. At the time of writing, follow-up was not complete for the whole cohort; 448 participants had completed follow-up. The study is observational, so it cannot show whether any marker predicts response to a treatment.

The supplied text names Innovative Medicines Initiative as funder. It also says the project was designed by academic and industry partners in consultation with the European Medicines Agency.

Do not read this as evidence that autism can already be split into clinically useful biological subgroups or that any therapy should be chosen from these tests. The paper describes a study design and baseline data; validation and treatment-response results are planned, not reported.