Down SyndromeNCT00954382
Trends in Intellectual Development in Down Syndrome
An observational study of Down Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but not any investigation of domestic data in Taiwan was available. Individuals with DS are characterized by limited verbal development, and in this article, authors look into the diverging verbal-nonverbal abilities in the DS… Read more about this study
- Who is it for?
- Ages 3 months to 40 years
- Conditions the study is for
- Down Syndrome
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2009to Dec 2010
- 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 3 months to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Down syndrome
Who may be able to join
- Down syndrome with psychological test results
Who cannot join
- Comorbidity of severe Autism or visual/auditory impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei, 10041
Lih-Maan Chang, master, +886-2-23123456 ext. 67211, lmchang@ntu.edu.tw
Wuh-Liang Hwu, Ph.D.
About this study
Official title: Trends in Intellectual Development, and Diverging Verbal and Non-verbal Abilities in the Down Syndrome Phenotype
Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but not any investigation of domestic data in Taiwan was available. Individuals with DS are characterized by limited verbal development, and in this article, authors look into the diverging verbal-nonverbal abilities in the DS phenotype.
Read the detailed description
The present study investigated this by analysis the test results of development /intelligence scales. To compare initial cross-sectional data with longitudinal follow-up, about 12 people with DS were included.
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, IQ, mental age, neuropsychological function
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IQ trend | all subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
IQ
Measured: 2001-2010
Secondary outcomes (1)
mental age
Measured: 2001-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
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 National Taiwan University HospitalThe 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
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wuh-Liang Hwu, Ph.D., Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954382
- Sponsor's protocol ID
- 200904037R
- Status last verified
- Mar 2010
- First submitted
- 5 Aug 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in Intellectual Development, and Diverging Verbal and Non-verbal Abilities in the Down Syndrome Phenotype
- ClinicalTrials.gov ID
- NCT00954382
- Acronym / sponsor ID
- 200904037R
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, IQ, mental age, neuropsychological function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Aug 2009 (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.
Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but not any investigation of domestic data in Taiwan was available. Individuals with DS are characterized by limited verbal development, and in this article, authors look into the diverging verbal-nonverbal abilities in the DS phenotype.
Detailed description
The present study investigated this by analysis the test results of development /intelligence scales. To compare initial cross-sectional data with longitudinal follow-up, about 12 people with DS were included.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IQ trend | – | –all subjects |
Who may qualify
- Ages
- 3 months to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Down syndrome
Key inclusion criteria (1 listed)
- Down syndrome with psychological test results
Key exclusion criteria (1 listed)
- Comorbidity of severe Autism or visual/auditory impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IQ
Time frame: 2001-2010
1 secondary outcome
mental age
Time frame: 2001-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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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.
Wuh-Liang Hwu, Ph.D. principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lih-Maan Chang, master (+886-2-23123456 ext. 67211, lmchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IQ (time frame: 2001-2010). 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 18 Mar 2010.