NCT01580384

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

March 23, 2012

Last Update Submit

March 2, 2015

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    approximately 1.5 years

Secondary Outcomes (3)

  • Test/re-test reliability: Changes in test results over 4 weeks

    approximately 1.5 years

  • Changes in test results over 6 month interval

    approximately 1.5 years

  • Correlations between test results on functioning, adaptive behavior and cognition and IQ level

    approximately 1.5 years

Study Arms (1)

Cohort

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with Down Syndrome

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Tucson, Arizona, 85721, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Ciudad Autonoma de Bs As, 1426, Argentina

Location

Unknown Facility

Ciudad de Buenos Aires, C1405BOA, Argentina

Location

Unknown Facility

Kentville, Nova Scotia, B4N 4K9, Canada

Location

Unknown Facility

Paris, 75015, France

Location

Unknown Facility

Saint-Etienne, 42055, France

Location

Unknown Facility

Rome, Lazio, 00165, Italy

Location

Unknown Facility

Palermo, Sicily, 90127, Italy

Location

Unknown Facility

Barcelona, Barcelona, 08009, Spain

Location

Unknown Facility

London, W1W 7EJ, United Kingdom

Location

Unknown Facility

Redruth, TR15 2SP, United Kingdom

Location

Related Publications (1)

  • Spiridigliozzi GA, Goeldner C, Edgin J, Hart SJ, Noeldeke J, Squassante L, Visootsak J, Heller JH, Khwaja O, Kishnani PS, Liogier d'Ardhuy X. Adaptive behavior in adolescents and adults with Down syndrome: Results from a 6-month longitudinal study. Am J Med Genet A. 2019 Jan;179(1):85-93. doi: 10.1002/ajmg.a.60685. Epub 2018 Dec 20.

    PMID: 30569586DERIVED

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

April 19, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

GB(2)ES(1)US(2)AR(2)CA(1)FR(2)IT(2)