Down Syndrome Regression Disorder (DSRD) is a rare condition that can affect adolescents and adults with Down syndrome, resulting in the loss of language, adaptive skills, and social behaviors. This study will look at the safety and effectiveness of three different possible therapies for DSRD: lorazepam, IVIG, and tofacitinib.
Who can participate in this study?
This study is for individuals with Down syndrome ages eight to 30 who have a diagnosis or symptoms of DSRD including but not limited to:
- mutism (loss of speech)
- catatonia (unresponsive)
- hallucinations
- delusions (strong belief in something that is not real or true)
- depersonalization (detached, emotionless)
- insomnia (difficulty sleeping)
- aggression
*Participants must meet additional eligibility criteria.
Who cannot participate in this study?
Contact the study team for additional eligibility criteria.
Where does this study take place?
Children's Hospital Colorado and Children's Hospital Los Angeles
What activities are involved in this study?
Attend 8 study visits over 12 weeks in Denver, CO, or Los Angeles, CA. Follow one of three randomized treatment plans: lorazepam, IVIG, or tofacitinib. Additional testing and monitoring. Travel assistance available.
What is the expected time commitment of this study?
This trial consists of 8 study visits that include a 12-week treatment period with the possibility of additional visits. Total study duration is anticipated to be 4 to 6 months.
What languages does this study support?
English
Is compensation provided?
Yes
To learn more, visit our DSRD Study page. If you have any questions or are interested in joining the study, please contact the research team at DSresearch@cuanschutz.edu.