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NCT02431117 Clinical Trial

Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30

Down Syndrome Clinical Trial

Official title:
A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Japanese Individuals With Down Syndrome Aged 6-30

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02431117
Other study ID # JP29688
Secondary ID
Status Completed
Phase N/A
First received April 13, 2015
Last updated July 7, 2016
Start date June 2015
Est. completion date July 2016

Study information
Verified date July 2016
Source Chugai Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 30 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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