A Screening Protocol to Assess Adult and Adolescent Individuals with Down syndrome for Eligibility to Participate in an Upcoming Study to Evaluate the efficacy, safety and tolerability of RO5186582 (Study BP27832)

Study ID
STU 062013-038

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Elizabeth Bannister
214-648-4603
elizabeth.bannister@utsouthwestern.edu

Principal Investigator
Patricia Evans

Summary

This is a single visit study in which Down syndrome individuals will attend the clinical center to undergo assessments to evaluate their eligibility for potential enrollment in the future BP27832 Phase ii clinical study. Study participants may withdraw from this study at any time and for any reason.

Participant Eligibility

Study participants will be assessed on the following criteria that they will be required to meet in order to participate in the future Phase II study BP27832:

1. Males and females 18-30 years of age
2. Clinical diagnosis of Down syndrome (trisomy 21) documented by chromosomal analysis (karyotyping)
3. BMI 18-40 and 15-30 kg/m2 inclusive for adults and adolescents respectively
4. Ability to complete the Clinical Evaluation of Language Fundamentals (CELF)-preschool 2 word classes task
5. Study participant willing and assenting or consenting to participate
6. Parent or guardian willing to give written informed consent
7. Study participants must have a parent, or other reliable caregiver who will agree to accompany the study participant to clinic visits during the treatment study, BP27832
8. The parent or caregiver must be a constant and reliable informant with sufficient contact with the study participant to have detailed knowledge of the study participant's adaptive functioning in order to be able to complete assessments accurately
9. Study participants must be verbal and able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices as their primary form of communication
10. Study participants must have sufficient vision and hearing to participate in study evaluations
11. Subjects taking anti-epileptic medication must have been on a stable dose of anti-epileptic
medications for at least 4 weeks prior to enrollment in the treatment protocol and that there are no
anticipated changes to anti-epileptic drug (AED) doses; withdrawal of anti-epileptic medications; or
initiation of additional anti-epileptic medications during the treatment study conduct.