During the previous ENTRAIN clinical trial financed by the Foundation, it was demonstrated that intake of folinic acid improves learning ability in children with Down syndrome already being treated with thyroid hormone. These results were published in January 2010.

The ACTHYF clinical trial, led by the Jerome Lejeune Institute, was launched in April 2012. It aims to assess whether folinic acid (a molecule related to vitamin B9) when supplemented with a thyroid hormone improves psychomotor development of young children with trisomy 21.

The ACTHYF study will include 256 patients divided into 4 cohorts to obtain the most reliable results. To our knowledge, this therapeutic study is the largest ever undertaken to assess a medical treatment for trisomy 21. The final results will be available by 2017. The Lejeune Institute is currently partnering with a major university based clinical research center to serve as a secondary site for this study.

At all levels - scientific, medical and financial - ACTHYF strongly indicates the the level of commitment the Jerome Lejeune Foundation and Institute have to improving the lives of those living with Down syndrome. The international medical and scientific community are following this trial with great interest.

The ACTHYF study is being conducted on children, aged 6 to 18 months at the time of study entry. These are very young patients, early in their neurological development, where treatment effect should be most obvious. The participation of each child lasts for one year, with three visits to the clinic for evaluation. A psychometric evaluation and medical consultation are required at the beginning, mid-term, and at the end of their year-long participation. This research has received all regulatory approvals both in France and the US, and parents are informed in detail about the study before giving their written consent.