Down SyndromeNCT02451657
Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome
An observational study of Down Syndrome, run by Hoffmann-La Roche at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Down Syndrome
- How many people
- 40 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 2 Jun 2015to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
France4 sites
CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale
Bordeaux, 33076
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
Bron, 69003
CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
Montpellier, 34295
CHU de Saint Etienne; Service de Génétique
Saint-Etienne, 42055
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Duke Clin Rsch Institute
Durham, North Carolina, 27710
University of Arizona
Tucson, Arizona, 85724-5030
Spain3 sites
IMIM, Human Pharmacology and Clinical Neurosciences,
Barcelona, 08009
Hospital Infantil Universitario Niño Jesus; Pediatria Social
Madrid, 28009
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, La Coruña, 15706
About this study
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 Children With Down Syndrome
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.
- Conditions
- Down Syndrome
- Being tested
- No Intervention
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention was administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 6 months
Secondary outcomes (3)
Test/re-test reliability: Changes in test results over 6 months
Measured: approximately 6 months
Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population
Measured: approximately 6 months
Correlations between test results on functioning, adaptive behavior and cognition and IQ level
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start2 Jun 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451657
- Sponsor's protocol ID
- BP29589
- Status last verified
- Oct 2017
- First submitted
- 20 May 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT02451657
- Acronym / sponsor ID
- BP29589
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: No Intervention |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention was administered in this study | Other | Cohort |
Primary outcome
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 6 months
3 secondary outcomes
Test/re-test reliability: Changes in test results over 6 months
Time frame: approximately 6 months
Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population
Time frame: approximately 6 months
Correlations between test results on functioning, adaptive behavior and cognition and IQ level
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Hoffmann-La Roche at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.