NCT02451657

Brief Summary

The aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with Down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
3 countries

10 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

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

June 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

May 20, 2015

Last Update Submit

October 24, 2017

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 6 months

Secondary Outcomes (3)

  • Test/re-test reliability: Changes in test results over 6 months

    approximately 6 months

  • Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population

    approximately 6 months

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

    approximately 6 months

Study Arms (1)

Cohort

Other: No Intervention

Interventions

No InterventionOTHER

No intervention was administered in this study

Cohort

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.

You may qualify if:

  • Males and females aged 6 to 11 with diagnosis of Down syndrome (Trisomy 21). Children may have standard trisomy 21, Robertsonian translocation, isochromosome 21 (so called 21q21q Robertsonian translocation), Down syndrome with reciprocal translocation or mosaicism.
  • Down syndrome children meeting clinical diagnostic criteria for generalized anxiety disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate in the study provided they are considered clinically stable or on stable medication for at least 8 weeks prior to the baseline visit.
  • Parent or legal guardian/representative and caregiver willing to give written informed consent.
  • Subjects with sufficient vision and hearing to engage in study evaluations as referred by their parents. Mild hearing loss will be allowed.

You may not qualify if:

  • Children 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
  • Significant sleep disruption or moderate to severe untreated obstructive sleep apnea.
  • Any condition which would make the individual or the caregiver, in the opinion of the investigator, unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Arizona

Tucson, Arizona, 85724-5030, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke Clin Rsch Institute

Durham, North Carolina, 27710, United States

Location

CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale

Bordeaux, 33076, France

Location

Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

Bron, 69003, France

Location

CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

Montpellier, 34295, France

Location

CHU de Saint Etienne; Service de Génétique

Saint-Etienne, 42055, France

Location

Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

Santiago de Compostela, La Coruña, 15706, Spain

Location

IMIM, Human Pharmacology and Clinical Neurosciences,

Barcelona, 08009, Spain

Location

Hospital Infantil Universitario Niño Jesus; Pediatria Social

Madrid, 28009, Spain

Location

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

May 20, 2015

First Posted

May 22, 2015

Study Start

June 2, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

FR(4)US(3)ES(3)