Down SyndromeBORMATENCT04241042
Clinical Validation of the Bordeaux Maze Test
An observational study of Down Syndrome and Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Currently, the instruments used in translational studies related to cognition have proved to be inaccurate. For this reason, the objective of this study is to evaluate whether the Bordeaux Maze Test has adequate psychometric properties and is valid for its use to compare trials tested in preclinical (animal) studies… Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Healthy
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2019to Apr 2020
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Down syndrome volunteers are recruited from Down syndrome foundations and control volunteers from educational centres nearby the research institute.
Who may be able to join
- Down syndrome population:
- Males and females aged 16 to 35 years.
- Clinical diagnosis of DS (full trisomy 21 or translocated) confirmed by chromosomal analysis (karyotyping).
- Parent or legal guardian/representative and caregiver willing to give written informed consent.
- Study participants must have sufficient vision and hearing to participate in study evaluations. Mild hearing loss will be allowed.
- Availability of parent/caregiver to accompany the subject to clinical visits.
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- Subjects must be able to understand basic instructions.
- Parent or legal guardian/representative and caregiver willing to give written informed consent
- Normotypical population:
- Males and females aged 18 to 35 years.
- Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- Understanding and accepting the study procedures and signing the informed consent.
Who cannot join
- Study participants with a current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of any primary or secondary psychiatric diagnoses (such as autism spectrum disorder, attention deficit hyperactivity disorder, depression and conduct disorder). Participation are allowed as long as they are considered stable and their medication with a regime that does not change in the 6 weeks prior to enrolment and does not interfere with the progression of the study.
- Subjects with evidence of dementia or meeting clinical diagnoses for dementia.
- Subjects thyroid dysfunction or diabetes that is not adequately controlled or stabilized on treatment for at least 8 weeks prior to randomization.
- Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure.
- Subjects with past history of seizures from primary causes (such as West syndrome and Lennox-Gastaut syndrome) or secondary causes.
- Clinical history of moderate or severe Obstructive Sleep Apnea (OSA) as defined by Apnea-Hypopnea Index (AHI) (>15 events per hour not well controlled by positive airway pressure therapy with stable settings) for at least 3 months prior to screening visit.
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- Alcohol and/or substance use disorder in the past year.
- Concomitant disease or condition or any clinically significant finding at screening that could interfere with the conduct of the study, or that would, in the opinion of the investigator, could lead to an unacceptable risk to the subject in this study.
- Participation in other clinical trials in the last 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)
Barcelona, 08003
Rafael De la Torre Fornell, PhD, 0034933160484, rtorre@imim.es
Rafael de la Torre, PhD
About this study
Currently, the instruments used in translational studies related to cognition have proved to be inaccurate. For this reason, the objective of this study is to evaluate whether the Bordeaux Maze Test has adequate psychometric properties and is valid for its use to compare trials tested in preclinical (animal) studies and clinical population with Down syndrome. Specifically, it is intended to study the domains of memory (relational memory) and executive functions (work memory), both relevant in the cognitive functioning of the population with Down syndrome.
- Conditions
- Down Syndrome, Healthy
- 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 |
|---|---|---|
| Down syndrome volunteers | Males and females from 16 to 35 years | |
| Healthy volunteers | Males and females from 18 to 35 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Bordeaux Maze Test
To validate a novel neuropsychological test, the Bordeaux Maze Test for the evaluation of working memory in subjects with Down syndrome (DS)
Measured: Changes from months 0 to months 1 and 3
Secondary outcomes (6)
Test retest reliability
To validate the Bordeaux Maze Test, for the evaluation of cognitive flexibility in subjects with Down syndrome (DS)
Measured: months 0, 1 and 3
Criteria validity
To evaluate the influence of age and gender on the Bordeaux Maze Test in the Down syndrome population;
Measured: months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the Bordeaux Maze Test
To evaluate the relevance of learning/practice effects
Measured: months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the NIH Toolbox
To evaluate the relevance of learning/practice effects
Measured: months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test
To evaluate the relevance of floor/ceiling effects
Measured: months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox
To evaluate the relevance of floor/ceiling effects
Measured: months 0, 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start5 Apr 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Aelis Farma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241042
- Sponsor's protocol ID
- BORMATE/2
- Acronym
- BORMATE
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Bordeaux Maze Test
- ClinicalTrials.gov ID
- NCT04241042
- Acronym / sponsor ID
- BORMATE / BORMATE/2
- Conditions
- Down Syndrome, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Aelis Farma
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 27 Jan 2020 (actual)
- 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.
Currently, the instruments used in translational studies related to cognition have proved to be inaccurate. For this reason, the objective of this study is to evaluate whether the Bordeaux Maze Test has adequate psychometric properties and is valid for its use to compare trials tested in preclinical (animal) studies and clinical population with Down syndrome. Specifically, it is intended to study the domains of memory (relational memory) and executive functions (work memory), both relevant in the cognitive functioning of the population with Down syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down syndrome volunteers | – | –Males and females from 16 to 35 years |
| Healthy volunteers | – | –Males and females from 18 to 35 years |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Down syndrome volunteers are recruited from Down syndrome foundations and control volunteers from educational centres nearby the research institute.
Key inclusion criteria (12 listed)
- Down syndrome population:
- Normotypical population:
Key exclusion criteria (9 listed)
- Study participants with a current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of any primary or secondary psychiatric diagnoses (such as autism spectrum disorder, attention deficit hyperactivity disorder, depression and conduct disorder). Participation are allowed as long as they are considered stable and their medication with a regime that does not change in the 6 weeks prior to enrolment and does not interfere with the progression of the study.
- Subjects with evidence of dementia or meeting clinical diagnoses for dementia.
- Subjects thyroid dysfunction or diabetes that is not adequately controlled or stabilized on treatment for at least 8 weeks prior to randomization.
- Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure.
- Subjects with past history of seizures from primary causes (such as West syndrome and Lennox-Gastaut syndrome) or secondary causes.
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
Validation of the Bordeaux Maze Test
Time frame: Changes from months 0 to months 1 and 3
To validate a novel neuropsychological test, the Bordeaux Maze Test for the evaluation of working memory in subjects with Down syndrome (DS)
6 secondary outcomes
Test retest reliability
Time frame: months 0, 1 and 3
Criteria validity
Time frame: months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the Bordeaux Maze Test
Time frame: months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the NIH Toolbox
Time frame: months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test
Time frame: months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox
Time frame: months 0, 1 and 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
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 and Healthy, run by Parc de Salut Mar at 1 site in Spain.
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 12 inclusion and 9 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 27 Jan 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael de la Torre, Prof (+34933160484, rtorre@imim.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Bordeaux Maze Test (time frame: Changes from months 0 to months 1 and 3). 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 27 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.