Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30
Completed
- Conditions
- Down Syndrome
- Registration Number
- NCT02431117
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Subjects may have standard trisomy 21, Robertsonian translocation, isochromosome21,Down syndrome with reciprocal translocation or mosaicism.
- Availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms.
- Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening.
Exclusion Criteria
Individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values. 26 weeks
- Secondary Outcome Measures
Name Time Method