- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241042
Clinical Validation of the Bordeaux Maze Test (BORMATE)
January 22, 2020 updated by: Parc de Salut Mar
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rafael de la Torre, Prof
- Phone Number: +34933160484
- Email: rtorre@imim.es
Study Locations
-
-
-
Barcelona, Spain, 08003
- Recruiting
- IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)
-
Principal Investigator:
- Rafael de la Torre, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 35 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Down syndrome volunteers are recruited from Down syndrome foundations and control volunteers from educational centres nearby the research institute.
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Down syndrome volunteers
Males and females from 16 to 35 years
|
Healthy volunteers
Males and females from 18 to 35 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Changes from months 0 to months 1 and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test retest reliability
Time Frame: months 0, 1 and 3
|
To validate the Bordeaux Maze Test, for the evaluation of cognitive flexibility in subjects with Down syndrome (DS)
|
months 0, 1 and 3
|
Criteria validity
Time Frame: months 0, 1 and 3
|
To evaluate the influence of age and gender on the Bordeaux Maze Test in the Down syndrome population;
|
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
|
To evaluate the relevance of learning/practice effects
|
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
|
To evaluate the relevance of learning/practice effects
|
months 0, 1 and 3
|
Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test
Time Frame: months 0, 1 and 3
|
To evaluate the relevance of floor/ceiling effects
|
months 0, 1 and 3
|
Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox
Time Frame: months 0, 1 and 3
|
To evaluate the relevance of floor/ceiling effects
|
months 0, 1 and 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 5, 2019
Primary Completion (ANTICIPATED)
April 1, 2020
Study Completion (ANTICIPATED)
April 1, 2020
Study Registration Dates
First Submitted
November 13, 2019
First Submitted That Met QC Criteria
January 22, 2020
First Posted (ACTUAL)
January 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BORMATE/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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