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
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01580384
First received: March 23, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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.
| Condition |
|---|
|
Down Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Test/re-test reliability: Changes in test results over 4 weeks [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
- Changes in test results over 6 month interval [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
- Correlations between test results on functioning, adaptive behavior and cognition and IQ level [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 12 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Individuals with Down Syndrome
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580384
Contacts
| Contact: Please reference Study ID Number: BP25612 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Arizona | |
| Completed | |
| Tucson, Arizona, United States, 85721 | |
| United States, North Carolina | |
| Active, not recruiting | |
| Durham, North Carolina, United States, 27710 | |
| Argentina | |
| Recruiting | |
| Ciudad Autonoma de Bs As, Argentina, 1426 | |
| Recruiting | |
| Ciudad de Buenos Aires, Argentina, C1405BOA | |
| Canada, Nova Scotia | |
| Recruiting | |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| France | |
| Active, not recruiting | |
| Paris, France, 75015 | |
| Completed | |
| St Etienne, France, 42055 | |
| Italy | |
| Recruiting | |
| Palermo, Italy, 90127 | |
| Korea, Republic of | |
| Recruiting | |
| Busan-si, Korea, Republic of, 619-953 | |
| Spain | |
| Active, not recruiting | |
| Barcelona, Spain, 08009 | |
| United Kingdom | |
| Recruiting | |
| London, United Kingdom, W1W 7EJ | |
| Active, not recruiting | |
| Redruth, United Kingdom, TR15 2SP | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01580384 History of Changes |
| Other Study ID Numbers: | BP25612 |
| Study First Received: | March 23, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013