Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
12–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Individuals aged 12-30 years of age inclusive
Clinical diagnosis of Down syndrome (trisomy 21) confirmed by chromosomal analysis (karyotyping)
Males, or non-pregnant, non-lactating females. For females of childbearing potential, strict contraceptive prevention is required.
Body-mass Index (BMI) 18-42 and 15-30 kg/m2 inclusive for adults and adolescents respectively
Ability to complete the Clinical Evaluation of Language Fundamentals (CELF)-preschool 2 word classes task
Subjects must have a parent, or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with the medication schedule
Study participants must have sufficient language, vision and hearing to participate in study evaluations, as judged clinically by investigator
You may not be if
Subjects with a current DSM 5 diagnosis of any primary psychiatric diagnosis (including ASD or MDD)
Subjects with a history of infantile spasms, of West syndrome, Lennox-Gastaut syndrome, Early Infantile Epileptic Encephalopathy or any treatment-refractory epilepsy associated with cognitive or developmental regression, of severe head trauma or CNS infections (e.g. meningitis)
Subjects with a known or suspected clinical seizure event of any type within 24 months prior to screening
Clinically relevant ECG abnormalities at screening or baseline; QTcF above 450 ms; personal or family history (first degree relatives) of congenital long QT syndrome
