A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

March 2, 2015 updated by: Hoffmann-La Roche
This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Bs As, Argentina, 1426
      • Ciudad de Buenos Aires, Argentina, C1405BOA
  • Canada
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
  • France
      • Paris, France, 75015
      • St Etienne, France, 42055
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00165
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
  • Spain
      • Barcelona, Spain, 08009
  • United Kingdom
      • London, United Kingdom, W1W 7EJ
      • Redruth, United Kingdom, TR15 2SP
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
    • North Carolina
      • Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with Down Syndrome

Description

Inclusion Criteria:

  • Males and females, 12 to 30 years of age, with diagnosis of Down Syndrome
  • Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder can participate in the study provided they are on stable medication for at least 8 weeks prior to screening and likely to cooperate and take part successfully in the study assessments

Exclusion Criteria:

  • Subjects with DSM-IV axis I and II psychiatric disorders, except those authorized in the inclusion criteria
  • Subjects who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment
  • Subjects with evidence of dementia or meeting clinical diagnosis for dementia
  • Subjects with thyroid dysfunction or diabetes that is not adequately controlled and stabilized on treatment for at least 8 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurocognitive batteries/tests/scales: Suitability for individuals with Down syndrome assessed by number of tests completed/subjects completing, ceiling/floor effect, variance estimate of baseline/change from baseline
Time Frame: approximately 1.5 years
approximately 1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Test/re-test reliability: Changes in test results over 4 weeks
Time Frame: approximately 1.5 years
approximately 1.5 years
Changes in test results over 6 month interval
Time Frame: approximately 1.5 years
approximately 1.5 years
Correlations between test results on functioning, adaptive behavior and cognition and IQ level
Time Frame: approximately 1.5 years
approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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